Helmet NIV in Acute Respiratory Failure (HELMET)

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

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 Overview

• Status: Recruiting
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Device: Helmet Non-Invasive Ventilation; Device: Facemask Non-Invasive Ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dipayan Chaudhuri, MD; Phone Number: 9055212100; Email: dipayan.chaudhuri@medportal.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V1C3
      • Recruiting
      • Juravinski Hospital
      • Contact: Dipayan Chaudhuri, MD; Email: dipayan_c@hotmail.com
      • Principal Investigator: Bram Rochwerg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Helmet NIV; 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; 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.
Active Comparator: Facemask NIV; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Bram Rochwerg, MD, Hamilton Health Science

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: non-invasive ventilation; Helmet non-invasive ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: 13412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No