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.
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.
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
Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 1\) patients who are admitted to the adult ICU
* 2\) deemed to require NIV, as per the clinical team, for acute respiratory failure.
Exclusion Criteria:
* 1\) with impending cardiac arrest or need for intubation
* 2\) Glasgow coma scale \<9
* 3\) tracheostomy or upper airway obstruction
* 4\) elevated intracranial pressure
* 5\) untreated pneumothorax
* 6\) who refuse endotracheal intubation (do not intubate order documented)
* 7\) facial trauma
* 8\) are unable to wear the helmet or facemask
* 9\) who use NIV chronically
Primary outcome measure(s)
Consent Rate — 1 year Percentage of patients or SDMs approached for consent who give consent
Recruitment Rate — 1 year Number of patients recruited to the study per centre
Protocol adherence percentage — 1 year 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.
Trial sites (1)
Facility
City
Region
Status
Juravinski Hospital
Hamilton
Ontario
More Hamilton Health Sciences Corporation trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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