A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits

NCT04311320 | Completed DMC

• 1 other identifier: STUDY00008434
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Using a novel oxygen blender prototype with modified bCPAP to manage children 1 month to 5 years of age hospitalized with respiratory distress due to lower respiratory tract infection (LRTI) in low-resource settings is not associated with clinical failure within 1 hour of use. Aim: To investigate if this novel oxygen blender is safe to use among children 1 month to 5 years old hospitalized for respiratory distress from lower respiratory tract infections in a low-resource setting.

Conditions

Respiratory Distress Syndrome; Lower Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• Feasibility as Measured by Clinical Failure

  The primary outcome of this study is the feasibility of the investigational device as measured by clinical failure within 1 hour of installing the blender in the bubble continuous positive airway pressure (bCPAP) circuit. Clinical failure is defined as the occurrence of any of the following patient events: intubation, death, or transfer for higher level of care, or any 2 of the following events; \<85% O2 saturation after 30 min of treatment, new signs of respiratory distress, or partial pressure of carbon dioxide greater than 60 mmHg and pH less than 7.2 in capillary blood gas. Outcome will be reported as the percent of participants who experience clinical failure within 1 hour after blender installation.

  1 hour

Secondary Outcomes (9)

• Oxygen Saturation

  Approximately 7 days

• Oxygen Concentration of Outflow

  Approximately 7 days

• Flow of Oxygen from Tank

  Approximately 7 days

• Continuous Positive Air Pressure (CPAP) Level

  Approximately 7 days

• Bubble Continuous Positive Air Pressure (bCPAP) Maintenance

  Approximately 7 days

Study Arms (1)

Low-Resource Oxygen Blender

EXPERIMENTAL

This is a single-arm study. All participants will receive respiratory support using the investigational device.

Device: Low-Resource Oxygen Blender

Interventions

Low-Resource Oxygen Blender DEVICE

The device that is being evaluated is a novel low-cost, high access oxygen blender designed to be used in the World Health Organization bCPAP design. It functions by utilizing the Venturi effect, whereby a narrow jet of one fluid (i.e. oxygen) creates a suction effect and entrains surrounding ambient fluid (i.e. room air) into the jet, effectively creating a mixed solution of both fluids. The cost of materials amounts to approximately 1.40 U.S.D. The average time it takes to build a blender and incorporate it into a bCPAP circuit for a new user is approximately 16 minutes. The materials can all be found in a standard hospital, namely 3cc syringes with rubber stops and a 22 gauge hypodermic needle.

Low-Resource Oxygen Blender

Eligibility Criteria

• Age: 0 Days - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Admitted for lung disease and require hospitalization
• Admission diagnosis is lower respiratory tract infection or pneumonia or bronchiolitis (any infectious microbe including bacterial, viral, fungal, parasitic)
• Have respiratory distress on presentation to the hospital (cough or trouble breathing plus at least one of the following: \<92% despite low flow oxygen, central cyanosis, tachypnea, chest indrawing, nasal flaring, grunting, head nodding, convulsions, lethargy, inability to breastfeed or drink)
• A bCPAP (electronic) machine is not available to use

You may not qualify if:

• History of asthma
• Upper airway obstruction
• Diaphragmatic hernia
• Pneumothorax
• Acute Glasgow Coma score \<4
• Cleft Palate
• Cyanotic heart disease
• Bleeding disorders
• Imminent death within 2 hours
• Have had abdominal or thoracic surgery

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Chenla Children's Healthcare

Kratié, Kratié Province, 10109, Cambodia

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Andrew Wu, MD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 17, 2020
• Study Start: March 26, 2022
• Primary Completion: March 28, 2023
• Study Completion: December 31, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CA (1)