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

NCT03929484 | Terminated

• 1 other identifier: 16-21217
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Pneumonia Childhood

Keywords

Pneumonia; Hypoxemia; Oxygen therapy; Oxygen mask

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Protocol adherence

  2 hours

• Oxygen flow

  1 hour

• Oxygen saturation (SpO2)

  1 hour

• PCO2

  End of each period

• pH

  End of each period

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

Nasal reservoir cannula DEVICE

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.

Group A; Group B

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Infectious Diseases Research Collaboration, Uganda: collaborator
• Intellectual Ventures: collaborator
• Makerere University: collaborator

Study Sites (1)

Mulago Hospital

Kampala, Uganda

Location

MeSH Terms

Conditions

Pneumonia; Hypoxia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: April 26, 2019
• Study Start: September 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)