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

NCT ID: NCT04311320

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-26
• Study Completion Date: 2023-12-31

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.

Detailed Description

The study will be a prospective cohort feasibility and safety trial. Patients admitted to Chenla Children's Healthcare who meet eligibility criteria will be asked for consent and then enrolled. Once enrolled, the participant will be treated per hospital protocols and stabilized on bCPAP respiratory support. Once stable for 2 hours, the blender will be incorporated into the bCPAP circuit. At this point, the study nurses will begin recording data for the study as well as providing standard medical care per hospital protocols.

Conditions

Respiratory Distress Syndrome; Lower Respiratory Tract Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Low-Resource Oxygen Blender

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

Group Type: EXPERIMENTAL

Low-Resource Oxygen Blender

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Wu, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Chenla Children's Healthcare

Kratié, Kratié Province, Cambodia

Countries

Cambodia

Other Identifiers

STUDY00008434

Identifier Type: -

Identifier Source: org_study_id