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

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

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).

Study Overview

• Status: Terminated
• Conditions: Pneumonia Childhood
• Intervention / Treatment: Device: Nasal reservoir cannula

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Mulago Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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; 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.
Experimental: Group B; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Makerere University; Infectious Diseases Research Collaboration, Uganda; Intellectual Ventures

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Pneumonia; Oxygen therapy; Oxygen mask; Hypoxemia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 16-21217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No