Helmet NIV in Acute Respiratory Failure

Last updated: July 9, 2025
Sponsor: Hamilton Health Sciences Corporation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Acute Respiratory Distress Syndrome (Ards)

Respiratory Failure

Lung Injury

Treatment

Helmet Non-Invasive Ventilation

Facemask Non-Invasive Ventilation

Clinical Study ID

NCT05022173
13412
  • Ages > 16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Helmet Non-Invasive Ventilation
Phase:
Study Start date:
November 11, 2021
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Juravinski Hospital

    Hamilton, Ontario L8V1C3
    Canada

    Site Not Available

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