Back to resultsA Feasibility Study Evaluating a Novel Mask (Nasal Reservoir Cannula)
Primary Purpose
Pneumonia Childhood
Status
Terminated
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Nasal reservoir cannula
Sponsored by
About this trial
This is an interventional device feasibility trial for Pneumonia Childhood focused on measuring Pneumonia, Hypoxemia, Oxygen therapy, Oxygen mask
Eligibility Criteria
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
Sites / Locations
- Mulago Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Recruitment rate
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)
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
Protocol adherence
Proportion of enrolled children who completed the study, per protocol This will help inform the design of a definitive clinical trial.
Oxygen flow
Average oxygen flow, in liters per minute
Oxygen saturation (SpO2)
Average continuous oxygen saturation (SpO2) value
PCO2
PCO2 (capillary blood gas)
pH
pH (capillary blood gas)
Transcutaneous carbon dioxide (tcpCO2)
Average continuous transcutaneous carbon dioxide (tcpCO2) value
Full Information
NCT ID
NCT03929484
First Posted
March 2, 2018
Last Updated
April 24, 2019
Sponsor
University of California, San Francisco
Collaborators
Infectious Diseases Research Collaboration, Uganda, Intellectual Ventures, Makerere University
1. Study Identification
Unique Protocol Identification Number
NCT03929484
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Per sponsor advice
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Infectious Diseases Research Collaboration, Uganda, Intellectual Ventures, Makerere University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia Childhood
Keywords
Pneumonia, Hypoxemia, Oxygen therapy, Oxygen mask
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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).
Arm Title
Group B
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Nasal reservoir cannula
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Proportion of screened children who were enrolled This will help inform the design of a definitive clinical trial.
Time Frame
1 hour
Title
Estimated effect of novel mask on amount of oxygen used (compared to standard nasal cannula alone)
Description
Difference in volume of oxygen used, in liters (from cylinder) Estimation of effect size will help inform the design of a definitive clinical trial.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Protocol adherence
Description
Proportion of enrolled children who completed the study, per protocol This will help inform the design of a definitive clinical trial.
Time Frame
2 hours
Title
Oxygen flow
Description
Average oxygen flow, in liters per minute
Time Frame
1 hour
Title
Oxygen saturation (SpO2)
Description
Average continuous oxygen saturation (SpO2) value
Time Frame
1 hour
Title
PCO2
Description
PCO2 (capillary blood gas)
Time Frame
End of each period
Title
pH
Description
pH (capillary blood gas)
Time Frame
End of each period
Title
Transcutaneous carbon dioxide (tcpCO2)
Description
Average continuous transcutaneous carbon dioxide (tcpCO2) value
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mulago Hospital
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Plan to Share IPD
No
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A Feasibility Study Evaluating a Novel Mask (Nasal Reservoir Cannula)
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