Clinical trial NCT04311320: A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits
Official title: A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Lower Respiratory Tract Infection
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 33
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Feasibility as Measured by Clinical Failure
timeFrame: 1 hour
Secondary outcomes:
measure: Oxygen Saturation
timeFrame: Approximately 7 days
measure: Oxygen Concentration of Outflow
timeFrame: Approximately 7 days
measure: Flow of Oxygen from Tank
timeFrame: Approximately 7 days
measure: Continuous Positive Air Pressure (CPAP) Level
timeFrame: Approximately 7 days
measure: Bubble Continuous Positive Air Pressure (bCPAP) Maintenance
timeFrame: Approximately 7 days
measure: Blender Maintenance
timeFrame: Approximately 7 days
measure: Duration of Respiratory Support
timeFrame: Approximately 7 days
measure: Number of Patient Transfers
timeFrame: Approximately 7 days
measure: Number of Patient Intubations
timeFrame: Approximately 7 days
Other outcomes:
Locations:
city: Kratié
country: Cambodia
facility: Chenla Children's Healthcare
state: Kratié Province
Study officials:
affiliation: University of Minnesota
name: Andrew Wu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: