Helmet NIV in Acute Respiratory Failure

Not Applicable

Recruiting

• Conditions: Acute Respiratory Failure
• Interventions: Device: Helmet Non-Invasive Ventilation; Device: Facemask Non-Invasive Ventilation

• Registration Number: NCT05022173
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-26
• Study Start: 2021-11-11
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-09
• Primary Completion: 2024-06
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Helmet NIV	Helmet Non-Invasive Ventilation	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.
Facemask NIV	Facemask Non-Invasive Ventilation	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.

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	1 year	Number of patients recruited to the study per centre
Consent Rate	1 year	Percentage of patients or SDMs approached for consent who give consent
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 Outcome Measures

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

Trial Locations

Locations (1)

Juravinski Hospital; 🇨🇦 Hamilton, Ontario, Canada