Pneumonia Childhood
Conditions
Keywords
Pneumonia, Hypoxemia, Oxygen therapy, Oxygen mask
Brief summary
This study evaluates the addition of a novel mask (nasal reservoir cannula) to a standard nasal cannula during supplemental oxygenation for the treatment of hospitalized pediatric patients with hypoxemia due to severe pneumonia. Half of patients (Group A) will receive oxygen for 1 hour using a novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 1), followed by a 1-hour period of continued use of the standard nasal cannula delivery (Period 2). Half of patients (Group B) will receive oxygen for 1 hour using a standard nasal cannula (Period 1), followed by a 1-hour period of continued use of the novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 2).
Detailed description
Pneumonia is the leading infectious cause of death among children less than 5 years of age. Hypoxemia is a major fatal complication of pneumonia, and the risk of death increases with increasing severity of hypoxemia. Improving oxygen delivery and extending oxygen supplies to children with hypoxemia due to severe pneumonia could reduce mortality in resource-limited settings. Global Good has developed a low cost oxygen mask (nasal reservoir cannula) to more efficiently deliver oxygen to the pediatric patient by increasing dead space to recapture a portion of expelled oxygen using the spatial distribution of the nasal reservoir cannula volume and length of surface seal. This nasal reservoir cannula fits over a standard nasal cannula (also termed prong). The system is designed to reduce administered oxygen to deliver an equal or higher fraction of inspired oxygen (FiO2) per oxygen delivered (L/min) compared with a standard nasal cannula alone.
Interventions
DEVICENasal reservoir cannula
The experimental oxygen mask (nasal reservoir cannula) fits over a standard nasal cannula. The system is designed to reduce administered oxygen to deliver an equal or higher fraction of inspired oxygen (FiO2) per oxygen delivered (L/min) compared with a standard nasal cannula alone.
Sponsors
Infectious Diseases Research Collaboration, Uganda
Intellectual Ventures
Makerere University
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 1 and ≤ 6 years. 2. Severe pneumonia based on WHO criteria 3. SpO2 ≥ 85% and \< 94% by pulse oximetry on room air 4. Hospital admission based on clinician judgment 5. Written informed consent from parent(s)/guardian(s) of subjects must be obtained before any study procedure is performed 6. Body weight ≥ 8 kg and ≤ 26 kg
Exclusion criteria
1. Hypercapnia (pCO2 \> 55 mm Hg or 7.32 kPa) on room air 2. Acidosis / lactic acidosis (pH \<7.20 and/or lactate \>6 mg/dL) on room air 3. SpO2 \< 85% or ≥ 94% by pulse oximetry on room air 4. SICK score \> 2.4 5. Hemoglobin \< 7 g/dL 6. Facial abnormalities or trauma precluding use of mask and nasal prongs. 7. Requirement of intubation or non-invasive or invasive positive-pressure ventilation 8. Suspected or known pneumothorax 9. Body weight \< 8 kg or \> 26 kg 10. Hemodynamic instability based on clinician judgment 11. SpO2 \< 90% by pulse oximetry on oxygen, measured at the end of the enrollment and before initiation of Period 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 1 hour | Proportion of screened children who were enrolled This will help inform the design of a definitive clinical trial. |
| Estimated effect of novel mask on amount of oxygen used (compared to standard nasal cannula alone) | 1 hour | Difference in volume of oxygen used, in liters (from cylinder) Estimation of effect size will help inform the design of a definitive clinical trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transcutaneous carbon dioxide (tcpCO2) | 1 hour | Average continuous transcutaneous carbon dioxide (tcpCO2) value |
| Protocol adherence | 2 hours | Proportion of enrolled children who completed the study, per protocol This will help inform the design of a definitive clinical trial. |
| PCO2 | End of each period | PCO2 (capillary blood gas) |
| Oxygen saturation (SpO2) | 1 hour | Average continuous oxygen saturation (SpO2) value |
| Oxygen flow | 1 hour | Average oxygen flow, in liters per minute |
| pH | End of each period | pH (capillary blood gas) |
Countries
Uganda
Outcome results
None listed