Trial Outcomes & Findings for Pediatric Helmet CPAP Pilot Study (NCT NCT04764929)
NCT ID: NCT04764929
Last Updated: 2024-07-29
Results Overview
Tolerance is defined as the successful application and maintenance of helmet CPAP without any unplanned, prolonged (\>5 minutes) removals or disruptions.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Four hours
Results posted on
2024-07-29
Participant Flow
Participant milestones
| Measure |
Helmet CPAP
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.
Helmet CPAP: Vyatil nonpowered oxygen tent system
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pediatric Helmet CPAP Pilot Study
Baseline characteristics by cohort
| Measure |
Helmet CPAP
n=5 Participants
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.
Helmet CPAP: Vyatil nonpowered oxygen tent system
|
|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
|
Admission Diagnosis
Viral Bronchiolitis
|
3 Participants
n=99 Participants
|
|
Admission Diagnosis
Viral Pneumonia
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Four hoursTolerance is defined as the successful application and maintenance of helmet CPAP without any unplanned, prolonged (\>5 minutes) removals or disruptions.
Outcome measures
| Measure |
Helmet CPAP
n=5 Participants
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.
Helmet CPAP: Vyatil nonpowered oxygen tent system
|
|---|---|
|
Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours
|
5 Participants
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Data was not collected thus cannot be analyzed or reported.
Respiratory rate will be measured in breaths per minute every hour for four hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 hoursPopulation: Data was not collected thus cannot be analyzed or reported.
Heart rate will be measured in beats per minute every hour for 4 hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 hoursPopulation: Data was not collected thus cannot be analyzed or reported.
Pulse oxygen saturation will be measured as a percent every hour for 4 hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 hoursPopulation: Data was not collected thus cannot be analyzed or reported.
Systolic blood pressure will be measured in millimeters of mercury every hour for 4 hours.
Outcome measures
Outcome data not reported
Adverse Events
Helmet CPAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place