Bronchiolitis, ViralNCT04764929
Pediatric Helmet CPAP Pilot Study
A study testing Helmet CPAP in people with Bronchiolitis, Viral and Pneumonia, Viral, run by Columbia University at 1 site in United States.
Trial summary
This a research study to find out whether giving Continuous Positive Airway Pressure (CPAP) through a Helmet is the same or better than giving CPAP through a Facemask, Nasal Mask, or Nasal Prongs. CPAP can help kids with lung infections breathe easier. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Bronchiolitis, Viral, Pneumonia, Viral, Pneumonia, Bacterial
- What is being tested?
- Helmet CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2021to 14 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- One month to 5 years of age (inclusive) admitted to the PICU with community acquired pneumonia or bronchiolitis, having been stable on nasal or facemask CPAP for at least four hours but less than 48 hours, and parental informed consent.
Who cannot join
- Age less than 1 month or greater than 5 years
- Positive for COVID-19
- Need for invasive mechanical ventilation or higher levels of non-invasive ventilation such as bi-level positive airway pressure (BPAP)
- Unresponsiveness (GCS 8 or less)
- Hypotension as defined as a systolic blood pressure less than 5th percentile for age
- Existing head or neck trauma, known or suspected air leak syndrome (pneumothorax, pneumomediastinum, subcutaneous emphysema), known or suspected increased intracranial pressure
- Non-English speaking parent
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Helmet CPAP for Infants and Pediatric Patients With Acute Respiratory Distress
This a research study to find out whether giving Continuous Positive Airway Pressure (CPAP) through a Helmet is the same or better than giving CPAP through a Facemask, Nasal Mask, or Nasal Prongs. CPAP can help kids with lung infections breathe easier. The machine delivers pressurized air, which may help people with lung infections breathe more easily. Doctors routinely use a Facemask, Nasal Mask or Nasal Prongs to give CPAP for kids with lung infections, but the researchers want to know whether using Helmet CPAP is the same or better.
Read the detailed description
Prior clinical trials have demonstrated efficacy of Helmet CPAP in adults with acute respiratory distress syndrome, superior tolerance and improved respiratory scores compared to nasal/facial CPAP in infants, and no major safety concerns were identified with the use of helmet CPAP. This is a prospective pilot study to (1) determine if infants and pediatric patients requiring CPAP in the PICU will tolerate helmet CPAP for at least four hours, and (2) measure changes in the respiratory rate, oxygen saturation, heart rate and blood pressure over four hours. If helmet CPAP is found to be well tolerated in this small cohort, a larger study comparing it directly to other CPAP interfaces will be conducted.
- Conditions
- Bronchiolitis, Viral, Pneumonia, Viral, Pneumonia, Bacterial
- Being tested
- Helmet CPAP
- Medical subject headings
- Bronchiolitis, Viral, Pneumonia, Viral, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helmet CPAPDevice
Vyatil nonpowered oxygen tent system
| Study group | Role | What they receive |
|---|---|---|
| Helmet CPAP | Experimental | Patients in the Pediatric Intensive Care Unit (PICU) already receiving CPAP through a facemask or nasal prongs or mask for at least four hours but no more than 48 hours will be transitioned to the Vyatil nonpowered oxygen tent system (Rochester, NY) by trained respiratory therapists per the manufacture's instructions: patient's neck circumference will be measured with a soft tape measure to ensure appropriate sizing. The helmet will be connected to at least 30 liters per minute of high flow medical air with an oxygen blender. The expiratory limb will be attached to the positive end expiratory pressure (PEEP) valve (initially set at 5 centimeters of water pressure) connected to a high-efficiency particulate air (HEPA) filter to prevent any viral particles from being released into the environment. A disposable manometer will be used to measure the pressure within the helmet. Once the flow to the helmet interface is on, the helmet will be sealed and secured with the system's arm straps. Receives: Device: Helmet CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours
Tolerance is defined as the successful application and maintenance of helmet CPAP without any unplanned, prolonged (>5 minutes) removals or disruptions.
Measured: Four hours
Secondary outcomes (4)
Respiratory Rate
Respiratory rate will be measured in breaths per minute every hour for four hours.
Measured: 4 hours
Heart Rate
Heart rate will be measured in beats per minute every hour for 4 hours.
Measured: 4 hours
Oxygen Saturation
Pulse oxygen saturation will be measured as a percent every hour for 4 hours.
Measured: 4 hours
Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury every hour for 4 hours.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start7 Aug 2021
- Primary completion19 May 2022
- Study completion14 Jun 2023
Why it stopped: Investigators left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bronchiolitis, ViralStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764929
- Sponsor's protocol ID
- AAAT5640
- Status last verified
- Jul 2024
- First submitted
- 16 Feb 2021
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Pilot study
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helmet CPAP for Infants and Pediatric Patients With Acute Respiratory Distress
- ClinicalTrials.gov ID
- NCT04764929
- Acronym / sponsor ID
- AAAT5640
- Conditions
- Bronchiolitis, Viral, Pneumonia, Viral, Pneumonia, Bacterial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigators left the institution
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 7 Aug 2021 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This a research study to find out whether giving Continuous Positive Airway Pressure (CPAP) through a Helmet is the same or better than giving CPAP through a Facemask, Nasal Mask, or Nasal Prongs. CPAP can help kids with lung infections breathe easier. The machine delivers pressurized air, which may help people with lung infections breathe more easily. Doctors routinely use a Facemask, Nasal Mask or Nasal Prongs to give CPAP for kids with lung infections, but the researchers want to know whether using Helmet CPAP is the same or better.
Detailed description
Prior clinical trials have demonstrated efficacy of Helmet CPAP in adults with acute respiratory distress syndrome, superior tolerance and improved respiratory scores compared to nasal/facial CPAP in infants, and no major safety concerns were identified with the use of helmet CPAP. This is a prospective pilot study to (1) determine if infants and pediatric patients requiring CPAP in the PICU will tolerate helmet CPAP for at least four hours, and (2) measure changes in the respiratory rate, oxygen saturation, heart rate and blood pressure over four hours. If helmet CPAP is found to be well tolerated in this small cohort, a larger study comparing it directly to other CPAP interfaces will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Helmet CPAP | Experimental | Device: Helmet CPAPPatients in the Pediatric Intensive Care Unit (PICU) already receiving CPAP through a facemask or nasal prongs or mask for at least four hours but no more than 48 hours will be transitioned to the Vyatil nonpowered oxygen tent system (Rochester, NY) by trained respiratory therapists per the manufacture's instructions: patient's neck circumference will be measured with a soft tape measure to ensure appropriate sizing. The helmet will be connected to at least 30 liters per minute of high flow medical air with an oxygen blender. The expiratory limb will be attached to the positive end expiratory pressure (PEEP) valve (initially set at 5 centimeters of water pressure) connected to a high-efficiency particulate air (HEPA) filter to prevent any viral particles from being released into the environment. A disposable manometer will be used to measure the pressure within the helmet. Once the flow to the helmet interface is on, the helmet will be sealed and secured with the system's arm straps. |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- One month to 5 years of age (inclusive) admitted to the PICU with community acquired pneumonia or bronchiolitis, having been stable on nasal or facemask CPAP for at least four hours but less than 48 hours, and parental informed consent.
Key exclusion criteria (7 listed)
- Age less than 1 month or greater than 5 years
- Positive for COVID-19
- Need for invasive mechanical ventilation or higher levels of non-invasive ventilation such as bi-level positive airway pressure (BPAP)
- Unresponsiveness (GCS 8 or less)
- Hypotension as defined as a systolic blood pressure less than 5th percentile for age
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 |
|---|---|---|
| Helmet CPAPVyatil nonpowered oxygen tent system | Device | Helmet CPAP |
Primary outcome
Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours
Time frame: Four hours
Tolerance is defined as the successful application and maintenance of helmet CPAP without any unplanned, prolonged (>5 minutes) removals or disruptions.
4 secondary outcomes
Respiratory Rate
Time frame: 4 hours
Heart Rate
Time frame: 4 hours
Oxygen Saturation
Time frame: 4 hours
Systolic Blood Pressure
Time frame: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Pilot study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helmet CPAP in people with Bronchiolitis, Viral and Pneumonia, Viral, run by Columbia University at 1 site in United States.
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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours (time frame: Four hours). 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 29 Jul 2024.