Clinical trial NCT03929484: A Feasibility Study Evaluating a Novel Mask (Nasal Reservoir Cannula)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pneumonia Childhood
Keywords: Pneumonia
Hypoxemia
Oxygen therapy
Oxygen mask
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Research Collaboration, Uganda
name: Intellectual Ventures
name: Makerere University
First posted: 2019-04-26
Enrollment: 8
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 1 hour
measure: Estimated effect of novel mask on amount of oxygen used (compared to standard nasal cannula alone)
timeFrame: 1 hour
Secondary outcomes:
measure: Protocol adherence
timeFrame: 2 hours
measure: Oxygen flow
timeFrame: 1 hour
measure: Oxygen saturation (SpO2)
timeFrame: 1 hour
measure: PCO2
timeFrame: End of each period
measure: pH
timeFrame: End of each period
measure: Transcutaneous carbon dioxide (tcpCO2)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital
Study officials:
References: