Respiratory Distress SyndromeNCT04311320
A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits
A study testing Low-Resource Oxygen Blender in people with Respiratory Distress Syndrome and Lower Respiratory Tract Infection, run by University of Minnesota at 1 site in Cambodia.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 5 years
- Conditions the study is for
- Respiratory Distress Syndrome, Lower Respiratory Tract Infection
- What is being tested?
- Low-Resource Oxygen Blender
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCambodia
- Study dates
- 26 Mar 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- History of asthma
- Upper airway obstruction
- Diaphragmatic hernia
- Pneumothorax
- Acute Glasgow Coma score <4
- Cleft Palate
Show all 10Show fewer
- Cyanotic heart disease
- Bleeding disorders
- Imminent death within 2 hours
- Have had abdominal or thoracic surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Low-Resource Oxygen Blender
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Resource Oxygen BlenderDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Resource Oxygen Blender | Experimental | This is a single-arm study. All participants will receive respiratory support using the investigational device. Receives: Device: Low-Resource Oxygen Blender |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (9)
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.
Measured: Approximately 7 days
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.
Measured: Approximately 7 days
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.
Measured: Approximately 7 days
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.
Measured: Approximately 7 days
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.
Measured: Approximately 7 days
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.
Measured: Approximately 7 days
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.
Measured: Approximately 7 days
Number of Patient Transfers
Outcome is reported as number of patients who require transfer to a higher level of care.
Measured: Approximately 7 days
Number of Patient Intubations
Outcome is reported as number of patients requiring intubation.
Measured: Approximately 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start26 Mar 2022
- Primary completion28 Mar 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Wu, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311320
- Sponsor's protocol ID
- STUDY00008434
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2020
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits
- ClinicalTrials.gov ID
- NCT04311320
- Acronym / sponsor ID
- STUDY00008434
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 26 Mar 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Resource Oxygen Blender | Experimental | Device: Low-Resource Oxygen BlenderThis is a single-arm study. All participants will receive respiratory support using the investigational device. |
Who may qualify
- Ages
- 0 days to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- History of asthma
- Upper airway obstruction
- Diaphragmatic hernia
- Pneumothorax
- Acute Glasgow Coma score <4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Resource Oxygen BlenderThe 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. | Device | Low-Resource Oxygen Blender |
Primary outcome
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.
9 secondary outcomes
Oxygen Saturation
Time frame: Approximately 7 days
Oxygen Concentration of Outflow
Time frame: Approximately 7 days
Flow of Oxygen from Tank
Time frame: Approximately 7 days
Continuous Positive Air Pressure (CPAP) Level
Time frame: Approximately 7 days
Bubble Continuous Positive Air Pressure (bCPAP) Maintenance
Time frame: Approximately 7 days
Blender Maintenance
Time frame: Approximately 7 days
Duration of Respiratory Support
Time frame: Approximately 7 days
Number of Patient Transfers
Time frame: Approximately 7 days
Number of Patient Intubations
Time frame: Approximately 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Wu, MD, MPH principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Resource Oxygen Blender in people with Respiratory Distress Syndrome and Lower Respiratory Tract Infection, run by University of Minnesota at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Measured by Clinical Failure (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.