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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03929484

Recruitment Status Terminated (Per sponsor advice)

First Posted April 26, 2019

Last update posted April 26, 2019

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).

  • Condition or Disease:Pneumonia Childhood
  • Intervention/Treatment: Device: Nasal reservoir cannula
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • 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 2017
  • Actual Primary Completion Date: March 2018
  • Actual Study Completion Date: March 2018
Arms and interventions
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.
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 1 to 6 Year (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 55 mm Hg or 7.32 kPa) on room air

2. Acidosis / lactic acidosis (pH 6 mg/dL) on room air

3. SpO2 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 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

Contacts and Locations
Contacts
Locations

Uganda
Mulago Hospital
Kampala

Sponsors and Collaborators

University of California, San Francisco

Infectious Diseases Research Collaboration, Uganda

Intellectual Ventures

Makerere University

More Information
  • 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
  • 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: Pneumonia