An interventional study of Helmet CPAP in Bronchiolitis, Viral, Pneumonia, Viral and Pneumonia, Bacterial, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 1 Month to 5 Years. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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.
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.
30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.
This study's enrollment of 5 is below the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.
Browse Bronchiolitis, Viral studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Helmet CPAP
Vyatil nonpowered oxygen tent system
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.
Time frame: Four hours
Respiratory Rate
Respiratory rate will be measured in breaths per minute every hour for four hours.
Time frame: 4 hours
Heart Rate
Heart rate will be measured in beats per minute every hour for 4 hours.
Time frame: 4 hours
Oxygen Saturation
Pulse oxygen saturation will be measured as a percent every hour for 4 hours.
Time frame: 4 hours
Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury every hour for 4 hours.
Time frame: 4 hours
| Milestone | Helmet CPAP |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
Tolerance is defined as the successful application and maintenance of helmet CPAP without any unplanned, prolonged (\>5 minutes) removals or disruptions.
| Participants | Helmet CPAP |
|---|---|
| Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours | 5 |
Respiratory rate will be measured in breaths per minute every hour for four hours.
No measurements were reported for this outcome.
Heart rate will be measured in beats per minute every hour for 4 hours.
No measurements were reported for this outcome.
Pulse oxygen saturation will be measured as a percent every hour for 4 hours.
No measurements were reported for this outcome.
Systolic blood pressure will be measured in millimeters of mercury every hour for 4 hours.
No measurements were reported for this outcome.
Collected over Up to 4 hours. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Helmet CPAP | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Helmet CPAP |
|---|---|
| <=18 years | 5 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Helmet CPAP |
|---|---|
| Female | 3 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Helmet CPAP |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Helmet CPAP |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(Participants) | Helmet CPAP |
|---|---|
| United States | 5 |
| Admission Diagnosis(Participants) | Helmet CPAP |
|---|---|
| Viral Bronchiolitis | 3 |
| Viral Pneumonia | 2 |
Plan to share: No — Pilot study
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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