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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
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.
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.
Juravinski Hospital
Hamilton, Ontario, Canada
Consent Rate
Percentage of patients or SDMs approached for consent who give consent
Time frame: 1 year
Recruitment Rate
Number of patients recruited to the study per centre
Time frame: 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.
Time frame: 1 year
Endotracheal intubation
Number of patients requiring endotracheal intubation
Time frame: 28 days
ICU mortality
Number of patients who die in ICU
Time frame: 28 days
Hospital mortality
Number of patients who die in hospital
Time frame: 60 days
ICU length of stay
Number of days that each patient spends in ICU
Time frame: Censored at 28 days
Hospital length of stay
Number of days that each patients spends in hospital
Time frame: Censored at 60 days
Duration of non-invasive ventilation
Number of days that patient receives non-invasive ventilation
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Time frame: Censored at 28 days
Duration of invasive ventilation
Number of days that patient receives invasive ventilation
Time frame: Censored at 28 days
Adverse events
Any complications related to NIV use
Time frame: 28 days
Comfort
Patient comfort with non-invasive ventilation
Time frame: 28 days