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

University of Minnesota (UMN)

Status: Completed

Conditions: Respiratory Distress Syndrome; Lower Respiratory Tract Infection

Treatments: Device: Low-Resource Oxygen Blender

Study type: Interventional

Funder types: Other

Identifiers

NCT04311320

STUDY00008434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Low-Resource Oxygen Blender

Experimental group

Description:

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

Treatment:

Device: Low-Resource Oxygen Blender