A Feasibility Study Evaluating a Novel Mask (Nasal Reservoir Cannula)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility Study Evaluating a Novel Mask (Nasal Reservoir Cannula) Plus Nasal Cannula vs. Nasal Cannula Alone for Supplemental Oxygen Delivery in the Treatment of Hospitalized Pediatric Patients With Hypoxemia Due to Severe Pneumonia

Conditions
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Pneumonia Childhood

Intervention / Treatment
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* Device: Nasal reservoir cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 1 and ≤ 6 years. Severe pneumonia based on WHO criteria SpO2 ≥ 85% and < 94% by pulse oximetry on room air Hospital admission based on clinician judgment Written informed consent from parent(s)/guardian(s) of subjects must be obtained before any study procedure is performed Body weight ≥ 8 kg and ≤ 26 kg Exclusion Criteria: Hypercapnia (pCO2 > 55 mm Hg or 7.32 kPa) on room air Acidosis / lactic acidosis (pH <7.20 and/or lactate >6 mg/dL) on room air SpO2 < 85% or ≥ 94% by pulse oximetry on room air SICK score > 2.4 Hemoglobin < 7 g/dL Facial abnormalities or trauma precluding use of mask and nasal prongs. Requirement of intubation or non-invasive or invasive positive-pressure ventilation Suspected or known pneumothorax Body weight < 8 kg or > 26 kg Hemodynamic instability based on clinician judgment SpO2 < 90% by pulse oximetry on oxygen, measured at the end of the enrollment and before initiation of Period 1

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Each patient 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 alone (Period 2). | Device: Nasal reservoir cannula<br>* 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.<br>|
| Experimental: Group B<br>Each patient will receive oxygen for 1 hour using a standard nasal cannula alone (Period 1), followed by a 1-hour period of continued use of the novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 2). | Device: Nasal reservoir cannula<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Proportion of screened children who were enrolled This will help inform the design of a definitive clinical trial. | 1 hour | 
| Estimated effect of novel mask on amount of oxygen used (compared to standard nasal cannula alone) | Difference in volume of oxygen used, in liters (from cylinder) Estimation of effect size will help inform the design of a definitive clinical trial. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protocol adherence | Proportion of enrolled children who completed the study, per protocol This will help inform the design of a definitive clinical trial. | 2 hours | 
| Oxygen flow | Average oxygen flow, in liters per minute | 1 hour | 
| Oxygen saturation (SpO2) | Average continuous oxygen saturation (SpO2) value | 1 hour | 
| PCO2 | PCO2 (capillary blood gas) | End of each period | 
| pH | pH (capillary blood gas) | End of each period | 
| Transcutaneous carbon dioxide (tcpCO2) | Average continuous transcutaneous carbon dioxide (tcpCO2) value | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, Hypoxemia, Oxygen therapy, Oxygen mask