Back to resultsA Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits
Primary Purpose
Respiratory Distress Syndrome, Lower Respiratory Tract Infection
Status
Active
Phase
Not Applicable
Locations
Cambodia
Study Type
Interventional
Intervention
Low-Resource Oxygen Blender
Sponsored by
About this trial
This is an interventional device feasibility trial for Respiratory Distress Syndrome
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
Sites / Locations
- Chenla Children's Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low-Resource Oxygen Blender
Arm Description
This is a single-arm study. All participants will receive respiratory support using the investigational device.
Outcomes
Primary Outcome Measures
Feasibility as Measured by Clinical Failure
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 Outcome Measures
Oxygen Saturation
Oxygen saturation will be measured with pulse oximeter every 6 hours for the length of hospital submission. Outcome will be reported as mean of all measurements per patient. Units are percent.
Oxygen Concentration of Outflow
Oxygen concentration of outflow from nasal cannula will be measured with an oxygen analyzer every 6 hours for the length of hospital submission. Outcome will be reported as mean of all measurements per patient. Units are percent oxygen.
Flow of Oxygen from Tank
Flow of oxygen from tank will be measured with the gauge on the oxygen canister. Measurements will be recorded every 6 hours for the length of hospital submission. Outcome will be reported as mean of all measurements per patient in units of liters per minute.
Continuous Positive Air Pressure (CPAP) Level
CPAP level (as displayed on CPAP device) will be recorded every 6 hours for the length of hospital submission. Outcome will be reported as mean of all measurements per patient. This outcome measure is reported in units of cm of H2O.
Bubble Continuous Positive Air Pressure (bCPAP) Maintenance
bCPAP maintenance is defined as the number of times no bubbling in the water column is noted by study staff indicating the need for maintenance. Need for maintenance will be assessed every 2 hours for the length of hospital stay. Number of incidents per patient will be recorded and outcome will be reported as a mean value of all measurements per patient.
Blender Maintenance
Blender maintenance is defined as the number of times the blender needs to be repaired or replaced per patient. Need for maintenance will be assessed every 2 hours for the length of hospital stay. Number of incidents per patient will be recorded and outcome will be reported as mean value of all measurements per patient.
Duration of Respiratory Support
Outcome will be reported as the length of time (in hours) that respiratory support (i.e. requiring bCPAP and blender) is required during hospital submission.
Number of Patient Transfers
Outcome is reported as number of patients who require transfer to a higher level of care.
Number of Patient Intubations
Outcome is reported as number of patients requiring intubation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04311320
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 26, 2022 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Lower Respiratory Tract Infection
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-Resource Oxygen Blender
Arm Type
Experimental
Arm Description
This is a single-arm study. All participants will receive respiratory support using the investigational device.
Intervention Type
Device
Intervention Name(s)
Low-Resource Oxygen Blender
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility as Measured by Clinical Failure
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Oxygen Saturation
Description
Oxygen saturation will be measured with pulse oximeter every 6 hours for the length of hospital submission. Outcome will be reported as mean of all measurements per patient. Units are percent.
Time Frame
Approximately 7 days
Title
Oxygen Concentration of Outflow
Description
Oxygen concentration of outflow from nasal cannula will be measured with an oxygen analyzer every 6 hours for the length of hospital submission. Outcome will be reported as mean of all measurements per patient. Units are percent oxygen.
Time Frame
Approximately 7 days
Title
Flow of Oxygen from Tank
Description
Flow of oxygen from tank will be measured with the gauge on the oxygen canister. Measurements will be recorded every 6 hours for the length of hospital submission. Outcome will be reported as mean of all measurements per patient in units of liters per minute.
Time Frame
Approximately 7 days
Title
Continuous Positive Air Pressure (CPAP) Level
Description
CPAP level (as displayed on CPAP device) will be recorded every 6 hours for the length of hospital submission. Outcome will be reported as mean of all measurements per patient. This outcome measure is reported in units of cm of H2O.
Time Frame
Approximately 7 days
Title
Bubble Continuous Positive Air Pressure (bCPAP) Maintenance
Description
bCPAP maintenance is defined as the number of times no bubbling in the water column is noted by study staff indicating the need for maintenance. Need for maintenance will be assessed every 2 hours for the length of hospital stay. Number of incidents per patient will be recorded and outcome will be reported as a mean value of all measurements per patient.
Time Frame
Approximately 7 days
Title
Blender Maintenance
Description
Blender maintenance is defined as the number of times the blender needs to be repaired or replaced per patient. Need for maintenance will be assessed every 2 hours for the length of hospital stay. Number of incidents per patient will be recorded and outcome will be reported as mean value of all measurements per patient.
Time Frame
Approximately 7 days
Title
Duration of Respiratory Support
Description
Outcome will be reported as the length of time (in hours) that respiratory support (i.e. requiring bCPAP and blender) is required during hospital submission.
Time Frame
Approximately 7 days
Title
Number of Patient Transfers
Description
Outcome is reported as number of patients who require transfer to a higher level of care.
Time Frame
Approximately 7 days
Title
Number of Patient Intubations
Description
Outcome is reported as number of patients requiring intubation.
Time Frame
Approximately 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Wu, MD, MPH
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chenla Children's Healthcare
City
Kratié
State/Province
Kratié Province
ZIP/Postal Code
10109
Country
Cambodia
12. IPD Sharing Statement
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A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits
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