Helmet NIV in Acute Respiratory Failure

Study Overview
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Brief Summary
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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.

Official Title
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Helmet NIV Versus Facemask NIV in Acute Respiratory Failure: A Pilot Randomized Control Trial

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Device: Helmet Non-Invasive Ventilation
* Device: Facemask Non-Invasive Ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Helmet NIV<br>Patients randomized to the intervention arm will receive NIV through a phthalate free helmet (CaStar, STARMED) via an ICU ventilator in pressure support (PS) mode. | Device: Helmet Non-Invasive Ventilation<br>* 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.<br>|
| Active Comparator: Facemask NIV<br>Patients in the control arm will be randomized to the traditional facemask interface. The facemask group will use the same ICU ventilator being used for the helmet group. | Device: Facemask Non-Invasive Ventilation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consent Rate | Percentage of patients or SDMs approached for consent who give consent | 1 year | 
| Recruitment Rate | Number of patients recruited to the study per centre | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal intubation | Number of patients requiring endotracheal intubation | 28 days | 
| ICU mortality | Number of patients who die in ICU | 28 days | 
| Hospital mortality | Number of patients who die in hospital | 60 days | 
| ICU length of stay | Number of days that each patient spends in ICU | Censored at 28 days | 
| Hospital length of stay | Number of days that each patients spends in hospital | Censored at 60 days | 
| Duration of non-invasive ventilation | Number of days that patient receives non-invasive ventilation | Censored at 28 days | 
| Duration of invasive ventilation | Number of days that patient receives invasive ventilation | Censored at 28 days | 
| Adverse events | Any complications related to NIV use | 28 days | 
| Comfort | Patient comfort with non-invasive ventilation | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive ventilation, Helmet non-invasive ventilation