Efficacy and safety of oxygen-sparing nasal reservoir cannula for treatment of pediatric hypoxemic pneumonia in Uganda: a pilot randomized clinical trial.


Journal

BMC pulmonary medicine
ISSN: 1471-2466
Titre abrégé: BMC Pulm Med
Pays: England
ID NLM: 100968563

Informations de publication

Date de publication:
31 Aug 2020
Historique:
received: 26 03 2020
accepted: 18 08 2020
entrez: 2 9 2020
pubmed: 2 9 2020
medline: 8 6 2021
Statut: epublish

Résumé

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. (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. 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 The OSNRC enhances oxygen delivery without causing CO The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845 ; Date of registration: 15 July 2020).

Sections du résumé

BACKGROUND 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 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 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
CONCLUSION CONCLUSIONS
The OSNRC enhances oxygen delivery without causing CO
TRIAL REGISTRATION BACKGROUND
The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845 ; Date of registration: 15 July 2020).

Identifiants

pubmed: 32867735
doi: 10.1186/s12890-020-01267-8
pii: 10.1186/s12890-020-01267-8
pmc: PMC7457357
doi:

Substances chimiques

Oxygen S88TT14065

Types de publication

Comparative Study Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

230

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Auteurs

Jerry Mulondo (J)

Infectious Diseases Research Collaboration, Kampala, Uganda.

Stella Maleni (S)

Infectious Diseases Research Collaboration, Kampala, Uganda.

Hellen Aanyu-Tukamuhebwa (H)

Department of Pediatrics and Child Health, Mulago National Referral Hospital and Makerere University, Kampala, Uganda.

Ezekiel Mupere (E)

Department of Pediatrics and Child Health, Mulago National Referral Hospital and Makerere University, Kampala, Uganda.
Department of Pediatrics, Makerere University College of Health Sciences, Kampala, Uganda.

Alfred Onubia Andama (AO)

Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.

Chin Hei Ng (CH)

Intellectual Ventures, Global Good Fund, Bellevue, WA, USA.

Stephen Burkot (S)

Intellectual Ventures, Global Good Fund, Bellevue, WA, USA.

Ella M E Forgie (EME)

Department of Pediatrics, University of Alberta, 3-588D Edmonton Clinic Health Academy, 11405 87 Ave NW, Edmonton, Alberta, T6G 1C9, Canada.

Qaasim Mian (Q)

Department of Pediatrics, University of Alberta, 3-588D Edmonton Clinic Health Academy, 11405 87 Ave NW, Edmonton, Alberta, T6G 1C9, Canada.

Christine M Bachman (CM)

Intellectual Ventures, Global Good Fund, Bellevue, WA, USA.

Gerard Rummery (G)

ResMed Ltd., Bella Vista, Australia.

Daniel Lieberman (D)

Intellectual Ventures, Global Good Fund, Bellevue, WA, USA.

David Bell (D)

Intellectual Ventures, Global Good Fund, Bellevue, WA, USA.
, Present address: Issaquah, USA.

Michael T Hawkes (MT)

Department of Pediatrics, University of Alberta, 3-588D Edmonton Clinic Health Academy, 11405 87 Ave NW, Edmonton, Alberta, T6G 1C9, Canada. mthawkes@ualberta.ca.
Department of Medical Microbiology and Immunology, University of Alberta, Edmonton, Canada. mthawkes@ualberta.ca.
School of Public Health, University of Alberta, Edmonton, Canada. mthawkes@ualberta.ca.
Stollery Science Lab, Edmonton, Canada. mthawkes@ualberta.ca.
Women and Children's Health Research Institute, Edmonton, Canada. mthawkes@ualberta.ca.

Akos Somoskovi (A)

Intellectual Ventures, Global Good Fund, Bellevue, WA, USA.

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Classifications MeSH