Efficacy and safety of oxygen-sparing nasal reservoir cannula for treatment of pediatric hypoxemic pneumonia in Uganda: a pilot randomized clinical trial
Background Oxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Mulondo, Jerry [verfasserIn] Maleni, Stella [verfasserIn] Aanyu-Tukamuhebwa, Hellen [verfasserIn] Mupere, Ezekiel [verfasserIn] Andama, Alfred Onubia [verfasserIn] Ng, Chin Hei [verfasserIn] Burkot, Stephen [verfasserIn] Forgie, Ella M. E. [verfasserIn] Mian, Qaasim [verfasserIn] Bachman, Christine M. [verfasserIn] Rummery, Gerard [verfasserIn] Lieberman, Daniel [verfasserIn] Bell, David [verfasserIn] Hawkes, Michael T. [verfasserIn] Somoskovi, Akos [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2020 |
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| Übergeordnetes Werk: |
Enthalten in: BMC pulmonary medicine - London : BioMed Central, 2001, 20(2020), 1 vom: 31. Aug. |
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| Übergeordnetes Werk: |
volume:20 ; year:2020 ; number:1 ; day:31 ; month:08 |
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| DOI / URN: |
10.1186/s12890-020-01267-8 |
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| Katalog-ID: |
SPR040819833 |
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| 245 | 1 | 0 | |a Efficacy and safety of oxygen-sparing nasal reservoir cannula for treatment of pediatric hypoxemic pneumonia in Uganda: a pilot randomized clinical trial |
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| 520 | |a Background Oxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings. Methods (1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC. Results The laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood $ pCO_{2} $ was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with $ CO_{2} $ retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and $ SpO_{2} $. The OSNRC group had a higher mean $ SpO_{2} $ than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement. Conclusion The OSNRC enhances oxygen delivery without causing $ CO_{2} $ retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia. Trial registration The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845; Date of registration: 15 July 2020). | ||
| 650 | 4 | |a Oxygen |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Pneumonia |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Africa |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Child |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Nasal Canula |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Maleni, Stella |e verfasserin |4 aut | |
| 700 | 1 | |a Aanyu-Tukamuhebwa, Hellen |e verfasserin |4 aut | |
| 700 | 1 | |a Mupere, Ezekiel |e verfasserin |4 aut | |
| 700 | 1 | |a Andama, Alfred Onubia |e verfasserin |4 aut | |
| 700 | 1 | |a Ng, Chin Hei |e verfasserin |4 aut | |
| 700 | 1 | |a Burkot, Stephen |e verfasserin |4 aut | |
| 700 | 1 | |a Forgie, Ella M. E. |e verfasserin |4 aut | |
| 700 | 1 | |a Mian, Qaasim |e verfasserin |4 aut | |
| 700 | 1 | |a Bachman, Christine M. |e verfasserin |4 aut | |
| 700 | 1 | |a Rummery, Gerard |e verfasserin |4 aut | |
| 700 | 1 | |a Lieberman, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Bell, David |e verfasserin |4 aut | |
| 700 | 1 | |a Hawkes, Michael T. |e verfasserin |4 aut | |
| 700 | 1 | |a Somoskovi, Akos |e verfasserin |4 aut | |
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10.1186/s12890-020-01267-8 doi (DE-627)SPR040819833 (SPR)s12890-020-01267-8-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Mulondo, Jerry verfasserin aut Efficacy and safety of oxygen-sparing nasal reservoir cannula for treatment of pediatric hypoxemic pneumonia in Uganda: a pilot randomized clinical trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Oxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings. Methods (1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC. Results The laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood $ pCO_{2} $ was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with $ CO_{2} $ retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and $ SpO_{2} $. The OSNRC group had a higher mean $ SpO_{2} $ than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement. Conclusion The OSNRC enhances oxygen delivery without causing $ CO_{2} $ retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia. Trial registration The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845; Date of registration: 15 July 2020). Oxygen (dpeaa)DE-He213 Pneumonia (dpeaa)DE-He213 Africa (dpeaa)DE-He213 Child (dpeaa)DE-He213 Nasal Canula (dpeaa)DE-He213 Maleni, Stella verfasserin aut Aanyu-Tukamuhebwa, Hellen verfasserin aut Mupere, Ezekiel verfasserin aut Andama, Alfred Onubia verfasserin aut Ng, Chin Hei verfasserin aut Burkot, Stephen verfasserin aut Forgie, Ella M. E. verfasserin aut Mian, Qaasim verfasserin aut Bachman, Christine M. verfasserin aut Rummery, Gerard verfasserin aut Lieberman, Daniel verfasserin aut Bell, David verfasserin aut Hawkes, Michael T. verfasserin aut Somoskovi, Akos verfasserin aut Enthalten in BMC pulmonary medicine London : BioMed Central, 2001 20(2020), 1 vom: 31. Aug. (DE-627)335489125 (DE-600)2059871-3 1471-2466 nnns volume:20 year:2020 number:1 day:31 month:08 https://dx.doi.org/10.1186/s12890-020-01267-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 20 2020 1 31 08 |
| spelling |
10.1186/s12890-020-01267-8 doi (DE-627)SPR040819833 (SPR)s12890-020-01267-8-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Mulondo, Jerry verfasserin aut Efficacy and safety of oxygen-sparing nasal reservoir cannula for treatment of pediatric hypoxemic pneumonia in Uganda: a pilot randomized clinical trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Oxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings. Methods (1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC. Results The laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood $ pCO_{2} $ was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with $ CO_{2} $ retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and $ SpO_{2} $. The OSNRC group had a higher mean $ SpO_{2} $ than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement. Conclusion The OSNRC enhances oxygen delivery without causing $ CO_{2} $ retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia. Trial registration The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845; Date of registration: 15 July 2020). Oxygen (dpeaa)DE-He213 Pneumonia (dpeaa)DE-He213 Africa (dpeaa)DE-He213 Child (dpeaa)DE-He213 Nasal Canula (dpeaa)DE-He213 Maleni, Stella verfasserin aut Aanyu-Tukamuhebwa, Hellen verfasserin aut Mupere, Ezekiel verfasserin aut Andama, Alfred Onubia verfasserin aut Ng, Chin Hei verfasserin aut Burkot, Stephen verfasserin aut Forgie, Ella M. E. verfasserin aut Mian, Qaasim verfasserin aut Bachman, Christine M. verfasserin aut Rummery, Gerard verfasserin aut Lieberman, Daniel verfasserin aut Bell, David verfasserin aut Hawkes, Michael T. verfasserin aut Somoskovi, Akos verfasserin aut Enthalten in BMC pulmonary medicine London : BioMed Central, 2001 20(2020), 1 vom: 31. Aug. (DE-627)335489125 (DE-600)2059871-3 1471-2466 nnns volume:20 year:2020 number:1 day:31 month:08 https://dx.doi.org/10.1186/s12890-020-01267-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 20 2020 1 31 08 |
| allfields_unstemmed |
10.1186/s12890-020-01267-8 doi (DE-627)SPR040819833 (SPR)s12890-020-01267-8-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Mulondo, Jerry verfasserin aut Efficacy and safety of oxygen-sparing nasal reservoir cannula for treatment of pediatric hypoxemic pneumonia in Uganda: a pilot randomized clinical trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Oxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings. Methods (1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC. Results The laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood $ pCO_{2} $ was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with $ CO_{2} $ retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and $ SpO_{2} $. The OSNRC group had a higher mean $ SpO_{2} $ than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement. Conclusion The OSNRC enhances oxygen delivery without causing $ CO_{2} $ retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia. Trial registration The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845; Date of registration: 15 July 2020). Oxygen (dpeaa)DE-He213 Pneumonia (dpeaa)DE-He213 Africa (dpeaa)DE-He213 Child (dpeaa)DE-He213 Nasal Canula (dpeaa)DE-He213 Maleni, Stella verfasserin aut Aanyu-Tukamuhebwa, Hellen verfasserin aut Mupere, Ezekiel verfasserin aut Andama, Alfred Onubia verfasserin aut Ng, Chin Hei verfasserin aut Burkot, Stephen verfasserin aut Forgie, Ella M. E. verfasserin aut Mian, Qaasim verfasserin aut Bachman, Christine M. verfasserin aut Rummery, Gerard verfasserin aut Lieberman, Daniel verfasserin aut Bell, David verfasserin aut Hawkes, Michael T. verfasserin aut Somoskovi, Akos verfasserin aut Enthalten in BMC pulmonary medicine London : BioMed Central, 2001 20(2020), 1 vom: 31. Aug. (DE-627)335489125 (DE-600)2059871-3 1471-2466 nnns volume:20 year:2020 number:1 day:31 month:08 https://dx.doi.org/10.1186/s12890-020-01267-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 20 2020 1 31 08 |
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10.1186/s12890-020-01267-8 doi (DE-627)SPR040819833 (SPR)s12890-020-01267-8-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Mulondo, Jerry verfasserin aut Efficacy and safety of oxygen-sparing nasal reservoir cannula for treatment of pediatric hypoxemic pneumonia in Uganda: a pilot randomized clinical trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Oxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings. Methods (1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC. Results The laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood $ pCO_{2} $ was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with $ CO_{2} $ retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and $ SpO_{2} $. The OSNRC group had a higher mean $ SpO_{2} $ than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement. Conclusion The OSNRC enhances oxygen delivery without causing $ CO_{2} $ retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia. Trial registration The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845; Date of registration: 15 July 2020). Oxygen (dpeaa)DE-He213 Pneumonia (dpeaa)DE-He213 Africa (dpeaa)DE-He213 Child (dpeaa)DE-He213 Nasal Canula (dpeaa)DE-He213 Maleni, Stella verfasserin aut Aanyu-Tukamuhebwa, Hellen verfasserin aut Mupere, Ezekiel verfasserin aut Andama, Alfred Onubia verfasserin aut Ng, Chin Hei verfasserin aut Burkot, Stephen verfasserin aut Forgie, Ella M. E. verfasserin aut Mian, Qaasim verfasserin aut Bachman, Christine M. verfasserin aut Rummery, Gerard verfasserin aut Lieberman, Daniel verfasserin aut Bell, David verfasserin aut Hawkes, Michael T. verfasserin aut Somoskovi, Akos verfasserin aut Enthalten in BMC pulmonary medicine London : BioMed Central, 2001 20(2020), 1 vom: 31. Aug. (DE-627)335489125 (DE-600)2059871-3 1471-2466 nnns volume:20 year:2020 number:1 day:31 month:08 https://dx.doi.org/10.1186/s12890-020-01267-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 20 2020 1 31 08 |
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10.1186/s12890-020-01267-8 doi (DE-627)SPR040819833 (SPR)s12890-020-01267-8-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Mulondo, Jerry verfasserin aut Efficacy and safety of oxygen-sparing nasal reservoir cannula for treatment of pediatric hypoxemic pneumonia in Uganda: a pilot randomized clinical trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Oxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings. Methods (1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC. Results The laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood $ pCO_{2} $ was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with $ CO_{2} $ retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and $ SpO_{2} $. The OSNRC group had a higher mean $ SpO_{2} $ than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement. Conclusion The OSNRC enhances oxygen delivery without causing $ CO_{2} $ retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia. Trial registration The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845; Date of registration: 15 July 2020). Oxygen (dpeaa)DE-He213 Pneumonia (dpeaa)DE-He213 Africa (dpeaa)DE-He213 Child (dpeaa)DE-He213 Nasal Canula (dpeaa)DE-He213 Maleni, Stella verfasserin aut Aanyu-Tukamuhebwa, Hellen verfasserin aut Mupere, Ezekiel verfasserin aut Andama, Alfred Onubia verfasserin aut Ng, Chin Hei verfasserin aut Burkot, Stephen verfasserin aut Forgie, Ella M. E. verfasserin aut Mian, Qaasim verfasserin aut Bachman, Christine M. verfasserin aut Rummery, Gerard verfasserin aut Lieberman, Daniel verfasserin aut Bell, David verfasserin aut Hawkes, Michael T. verfasserin aut Somoskovi, Akos verfasserin aut Enthalten in BMC pulmonary medicine London : BioMed Central, 2001 20(2020), 1 vom: 31. Aug. (DE-627)335489125 (DE-600)2059871-3 1471-2466 nnns volume:20 year:2020 number:1 day:31 month:08 https://dx.doi.org/10.1186/s12890-020-01267-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 20 2020 1 31 08 |
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Enthalten in BMC pulmonary medicine 20(2020), 1 vom: 31. Aug. volume:20 year:2020 number:1 day:31 month:08 |
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Mulondo, Jerry @@aut@@ Maleni, Stella @@aut@@ Aanyu-Tukamuhebwa, Hellen @@aut@@ Mupere, Ezekiel @@aut@@ Andama, Alfred Onubia @@aut@@ Ng, Chin Hei @@aut@@ Burkot, Stephen @@aut@@ Forgie, Ella M. E. @@aut@@ Mian, Qaasim @@aut@@ Bachman, Christine M. @@aut@@ Rummery, Gerard @@aut@@ Lieberman, Daniel @@aut@@ Bell, David @@aut@@ Hawkes, Michael T. @@aut@@ Somoskovi, Akos @@aut@@ |
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2020-08-31T00:00:00Z |
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Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings. Methods (1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC. Results The laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood $ pCO_{2} $ was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with $ CO_{2} $ retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and $ SpO_{2} $. The OSNRC group had a higher mean $ SpO_{2} $ than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement. Conclusion The OSNRC enhances oxygen delivery without causing $ CO_{2} $ retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia. 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610 ASE 44.00 bkl Efficacy and safety of oxygen-sparing nasal reservoir cannula for treatment of pediatric hypoxemic pneumonia in Uganda: a pilot randomized clinical trial Oxygen (dpeaa)DE-He213 Pneumonia (dpeaa)DE-He213 Africa (dpeaa)DE-He213 Child (dpeaa)DE-He213 Nasal Canula (dpeaa)DE-He213 |
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Mulondo, Jerry Maleni, Stella Aanyu-Tukamuhebwa, Hellen Mupere, Ezekiel Andama, Alfred Onubia Ng, Chin Hei Burkot, Stephen Forgie, Ella M. E. Mian, Qaasim Bachman, Christine M. Rummery, Gerard Lieberman, Daniel Bell, David Hawkes, Michael T. Somoskovi, Akos |
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efficacy and safety of oxygen-sparing nasal reservoir cannula for treatment of pediatric hypoxemic pneumonia in uganda: a pilot randomized clinical trial |
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Efficacy and safety of oxygen-sparing nasal reservoir cannula for treatment of pediatric hypoxemic pneumonia in Uganda: a pilot randomized clinical trial |
| abstract |
Background Oxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings. Methods (1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC. Results The laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood $ pCO_{2} $ was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with $ CO_{2} $ retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and $ SpO_{2} $. The OSNRC group had a higher mean $ SpO_{2} $ than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement. Conclusion The OSNRC enhances oxygen delivery without causing $ CO_{2} $ retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia. Trial registration The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845; Date of registration: 15 July 2020). |
| abstractGer |
Background Oxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings. Methods (1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC. Results The laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood $ pCO_{2} $ was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with $ CO_{2} $ retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and $ SpO_{2} $. The OSNRC group had a higher mean $ SpO_{2} $ than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement. Conclusion The OSNRC enhances oxygen delivery without causing $ CO_{2} $ retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia. Trial registration The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845; Date of registration: 15 July 2020). |
| abstract_unstemmed |
Background Oxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings. Methods (1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC. Results The laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood $ pCO_{2} $ was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with $ CO_{2} $ retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and $ SpO_{2} $. The OSNRC group had a higher mean $ SpO_{2} $ than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement. Conclusion The OSNRC enhances oxygen delivery without causing $ CO_{2} $ retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia. Trial registration The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845; Date of registration: 15 July 2020). |
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| score |
7.39979 |