A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Feasibility as Measured by Clinical Failure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 0 Days to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Low-Resource Oxygen Blender
This is a single-arm study. All participants will receive respiratory support using the investigational device.
Intervention: Low-Resource Oxygen Blender (Device)
Outcomes
Primary Outcomes
Feasibility as Measured by Clinical Failure
Time Frame: 1 hour
The primary outcome of this study is the feasibility of the investigational device as measured by clinical failure within 1 hour of installing the blender in the bubble continuous positive airway pressure (bCPAP) circuit. Clinical failure is defined as the occurrence of any of the following patient events: intubation, death, or transfer for higher level of care, or any 2 of the following events; \<85% O2 saturation after 30 min of treatment, new signs of respiratory distress, or partial pressure of carbon dioxide greater than 60 mmHg and pH less than 7.2 in capillary blood gas. Outcome will be reported as the percent of participants who experience clinical failure within 1 hour after blender installation.
Secondary Outcomes
- Blender Maintenance(Approximately 7 days)
- Oxygen Saturation(Approximately 7 days)
- Continuous Positive Air Pressure (CPAP) Level(Approximately 7 days)
- Number of Patient Intubations(Approximately 7 days)
- Oxygen Concentration of Outflow(Approximately 7 days)
- Flow of Oxygen from Tank(Approximately 7 days)
- Bubble Continuous Positive Air Pressure (bCPAP) Maintenance(Approximately 7 days)
- Duration of Respiratory Support(Approximately 7 days)
- Number of Patient Transfers(Approximately 7 days)