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

Not Applicable

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group B	Nasal reservoir cannula	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).
Group A	Nasal reservoir cannula	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Oxygen saturation (SpO2)	1 hour	Average continuous oxygen saturation (SpO2) value
PCO2	End of each period	PCO2 (capillary blood gas)
pH	End of each period	pH (capillary blood gas)
Transcutaneous carbon dioxide (tcpCO2)	1 hour	Average continuous transcutaneous carbon dioxide (tcpCO2) value
Oxygen flow	1 hour	Average oxygen flow, in liters per minute