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

NCT04311320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-04-15

No results posted yet for this study

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

Interventions

DEVICE

Low-Resource Oxygen Blender

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.

Sponsors & Collaborators

Principal Investigators

  • Andrew Wu, MD, MPH · University of Minnesota

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-26
Primary Completion
2023-03-28
Completion
2023-12-31

Countries

  • Cambodia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311320 on ClinicalTrials.gov