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

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ClinicalTrials.gov Identifier: NCT03929484
Recruitment Status : Terminated (Per sponsor advice)
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
Infectious Diseases Research Collaboration, Uganda
Intellectual Ventures
Makerere University
Information provided by (Responsible Party):
University of California, San Francisco

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).

Condition or disease Intervention/treatment Phase
Pneumonia Childhood Device: Nasal reservoir cannula Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 1 hour ]
    Proportion of screened children who were enrolled This will help inform the design of a definitive clinical trial.

  2. Estimated effect of novel mask on amount of oxygen used (compared to standard nasal cannula alone) [ Time Frame: 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 :
  1. Protocol adherence [ Time Frame: 2 hours ]
    Proportion of enrolled children who completed the study, per protocol This will help inform the design of a definitive clinical trial.

  2. Oxygen flow [ Time Frame: 1 hour ]
    Average oxygen flow, in liters per minute

  3. Oxygen saturation (SpO2) [ Time Frame: 1 hour ]
    Average continuous oxygen saturation (SpO2) value

  4. PCO2 [ Time Frame: End of each period ]
    PCO2 (capillary blood gas)

  5. pH [ Time Frame: End of each period ]
    pH (capillary blood gas)

  6. Transcutaneous carbon dioxide (tcpCO2) [ Time Frame: 1 hour ]
    Average continuous transcutaneous carbon dioxide (tcpCO2) value



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929484


Locations
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Uganda
Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
University of California, San Francisco
Infectious Diseases Research Collaboration, Uganda
Intellectual Ventures
Makerere University

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03929484     History of Changes
Other Study ID Numbers: 16-21217
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
Pneumonia
Hypoxemia
Oxygen therapy
Oxygen mask

Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections