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

NCT ID: NCT03929484

Last Updated: 2019-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-03-31

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.

Conditions

Pneumonia Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Nasal reservoir cannula

Intervention Type: 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 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).

Group Type: EXPERIMENTAL

Nasal reservoir cannula

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Infectious Diseases Research Collaboration, Uganda

OTHER

Sponsor Role: collaborator

Intellectual Ventures

UNKNOWN

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mulago Hospital

Kampala, , Uganda

Countries

Uganda

Other Identifiers

16-21217

Identifier Type: -

Identifier Source: org_study_id