Status:
COMPLETED
A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits
Lead Sponsor:
University of Minnesota
Conditions:
Respiratory Distress Syndrome
Lower Respiratory Tract Infection
Eligibility:
All Genders
Up to 5 years
Phase:
NA
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) ...
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04311320
Start Date
March 26 2022
End Date
December 31 2023
Last Update
April 15 2024
Active Locations (1)
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1
Chenla Children's Healthcare
Kratié, Kratié Province, Cambodia, 10109