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

Pneumonia Childhood Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03929484
• Other study ID #: 16-21217
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia Childhood

Intervention

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.

Locations

Country	Name	City	State
Uganda	Mulago Hospital	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Infectious Diseases Research Collaboration, Uganda, Intellectual Ventures, Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Proportion of screened children who were enrolled This will help inform the design of a definitive clinical trial.	1 hour
Primary	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	Protocol adherence	Proportion of enrolled children who completed the study, per protocol This will help inform the design of a definitive clinical trial.	2 hours
Secondary	Oxygen flow	Average oxygen flow, in liters per minute	1 hour
Secondary	Oxygen saturation (SpO2)	Average continuous oxygen saturation (SpO2) value	1 hour
Secondary	PCO2	PCO2 (capillary blood gas)	End of each period
Secondary	pH	pH (capillary blood gas)	End of each period
Secondary	Transcutaneous carbon dioxide (tcpCO2)	Average continuous transcutaneous carbon dioxide (tcpCO2) value	1 hour