Helmet NIV Versus Facemask NIV in Acute Respiratory Failure: A Pilot Randomized Control Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Respiratory Failure
- Sponsor
- Hamilton Health Sciences Corporation
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Recruitment Rate
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients who are admitted to the adult ICU
- •deemed to require NIV, as per the clinical team, for acute respiratory failure.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Recruitment Rate
Time Frame: 1 year
Number of patients recruited to the study per centre
Consent Rate
Time Frame: 1 year
Percentage of patients or SDMs approached for consent who give consent
Protocol adherence percentage
Time Frame: 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 Outcomes
- Endotracheal intubation(28 days)
- Hospital mortality(60 days)
- Duration of invasive ventilation(Censored at 28 days)
- ICU mortality(28 days)
- Adverse events(28 days)
- ICU length of stay(Censored at 28 days)
- Duration of non-invasive ventilation(Censored at 28 days)
- Comfort(28 days)
- Hospital length of stay(Censored at 60 days)