NCT05022173

Helmet NIV in Acute Respiratory Failure

Helmet NIV Versus Facemask NIV in Acute Respiratory Failure: A Pilot Randomized Control Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Non-invasive ventilation (NIV) is a form of respiratory support that has been shown to prevent invasive mechanical ventilation and reduce mortality. This study will investigate the feasibility of performing a larger study examining whether a new modality of NIV, the helmet, is superior to the current face mask in reducing mortality in patients with sudden respiratory failure.

Conditions

• Acute Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Helmet Non-Invasive Ventilation	The helmet interface is a modality which is used to deliver NIV to patients with respiratory failure. A transparent hood is placed over the entire head of the patient with a seal at the neck using a soft collar.
DEVICE	Facemask Non-Invasive Ventilation	The facemask interface is a modality which is also used to deliver NIV to patients with respiratory failure. A large mask covering the mouth and nose is strapped to the patient's face to create a seal.

Timeline

• Start date: 2021-11-11
• Primary completion: 2025-09-01
• Completion: 2025-11-01
• First posted: 2021-08-26
• Last updated: 2025-07-14

Locations

1 site across 1 country: Canada