Helmet NIV in Acute Respiratory Failure

NCT05022173 | Active Not Recruiting DMC

• 1 other identifier: 13412
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

non-invasive ventilation; Helmet non-invasive ventilation

Outcome Measures

Primary Outcomes (3)

• Consent Rate

  Percentage of patients or SDMs approached for consent who give consent

  1 year

• Recruitment Rate

  Number of patients recruited to the study per centre

  1 year

• Protocol adherence percentage

  Adherence to pre-specified fixed protocol on how helmet interface is implemented (settings, weaning etc.) Any protocol deviations will be recorded and marked as protocol non-adherence.

  1 year

Secondary Outcomes (9)

• Endotracheal intubation

  28 days

• ICU mortality

  28 days

• Hospital mortality

  60 days

• ICU length of stay

  Censored at 28 days

• Hospital length of stay

  Censored at 60 days

Study Arms (2)

Helmet NIV

EXPERIMENTAL

Patients randomized to the intervention arm will receive NIV through a phthalate free helmet (CaStar, STARMED) via an ICU ventilator in pressure support (PS) mode.

Device: Helmet Non-Invasive Ventilation

Facemask NIV

ACTIVE COMPARATOR

Patients in the control arm will be randomized to the traditional facemask interface. The facemask group will use the same ICU ventilator being used for the helmet group.

Device: Facemask Non-Invasive Ventilation

Interventions

Helmet Non-Invasive Ventilation DEVICE

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.

Helmet NIV

Facemask Non-Invasive Ventilation DEVICE

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.

Facemask NIV

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) patients who are admitted to the adult ICU
• \) deemed to require NIV, as per the clinical team, for acute respiratory failure.

You may not qualify if:

• \) with impending cardiac arrest or need for intubation
• \) Glasgow coma scale \<9
• \) tracheostomy or upper airway obstruction
• \) elevated intracranial pressure
• \) untreated pneumothorax
• \) who refuse endotracheal intubation (do not intubate order documented)
• \) facial trauma
• \) are unable to wear the helmet or facemask
• \) who use NIV chronically

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Juravinski Hospital

Hamilton, Ontario, L8V1C3, Canada

Location

Study Officials

• Bram Rochwerg, MD

  Hamilton Health Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 26, 2021
• Study Start: November 11, 2021
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

CA (1)