Bronchiolitis, Viral, Pneumonia, Viral, Pneumonia, Bacterial
Conditions
Brief 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. 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.
Interventions
DEVICEHelmet CPAP
Vyatil nonpowered oxygen tent system
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours | Four hours | Tolerance is defined as the successful application and maintenance of helmet CPAP without any unplanned, prolonged (\>5 minutes) removals or disruptions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate | 4 hours | Respiratory rate will be measured in breaths per minute every hour for four hours. |
| Heart Rate | 4 hours | Heart rate will be measured in beats per minute every hour for 4 hours. |
| Oxygen Saturation | 4 hours | Pulse oxygen saturation will be measured as a percent every hour for 4 hours. |
| Systolic Blood Pressure | 4 hours | Systolic blood pressure will be measured in millimeters of mercury every hour for 4 hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Helmet CPAP |
|---|---|
| Admission Diagnosis Viral Bronchiolitis | 3 Participants |
| Admission Diagnosis Viral Pneumonia | 2 Participants |
| Age, Categorical <=18 years | 5 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Helmet CPAP | Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours | 5 Participants |
Secondary
Heart Rate
Heart rate will be measured in beats per minute every hour for 4 hours.
Time frame: 4 hours
Population: Data was not collected thus cannot be analyzed or reported.
Secondary
Oxygen Saturation
Pulse oxygen saturation will be measured as a percent every hour for 4 hours.
Time frame: 4 hours
Population: Data was not collected thus cannot be analyzed or reported.
Secondary
Respiratory Rate
Respiratory rate will be measured in breaths per minute every hour for four hours.
Time frame: 4 hours
Population: Data was not collected thus cannot be analyzed or reported.
Secondary
Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury every hour for 4 hours.
Time frame: 4 hours
Population: Data was not collected thus cannot be analyzed or reported.