Acute Respiratory Failure
Conditions
Keywords
non-invasive ventilation, Helmet non-invasive ventilation
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.
Interventions
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.
DEVICEFacemask 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.
Sponsors
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU length of stay | Censored at 28 days | Number of days that each patient spends in ICU |
| Hospital length of stay | Censored at 60 days | Number of days that each patients spends in hospital |
| Duration of non-invasive ventilation | Censored at 28 days | Number of days that patient receives non-invasive ventilation |
| Endotracheal intubation | 28 days | Number of patients requiring endotracheal intubation |
| Adverse events | 28 days | Any complications related to NIV use |
| Comfort | 28 days | Patient comfort with non-invasive ventilation |
| Duration of invasive ventilation | Censored at 28 days | Number of days that patient receives invasive ventilation |
| ICU mortality | 28 days | Number of patients who die in ICU |
| Hospital mortality | 60 days | Number of patients who die in hospital |
Countries
Canada
Outcome results
None listed