NCT04764929

Pediatric Helmet CPAP Pilot Study

Helmet CPAP for Infants and Pediatric Patients With Acute Respiratory Distress

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 1 Month – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiolitis, Viral
• Pneumonia, Viral
• Pneumonia, Bacterial

Interventions

Type	Name	Description
DEVICE	Helmet CPAP	Vyatil nonpowered oxygen tent system

Timeline

• Start date: 2021-08-07
• Primary completion: 2022-05-19
• Completion: 2023-06-14
• First posted: 2021-02-21
• Last updated: 2024-07-29
• Results posted: 2024-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study