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Helmet NIV in Acute Respiratory Failure (HELMET)

Primary Purpose

Acute Respiratory Failure

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Helmet Non-Invasive Ventilation

Facemask Non-Invasive Ventilation

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring non-invasive ventilation, Helmet non-invasive ventilation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Juravinski HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Helmet NIV

Facemask NIV

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Consent Rate

Percentage of patients or SDMs approached for consent who give consent

Recruitment Rate

Number of patients recruited to the study per centre

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.

Secondary Outcome Measures

Endotracheal intubation

Number of patients requiring endotracheal intubation

ICU mortality

Number of patients who die in ICU

Hospital mortality

Number of patients who die in hospital

ICU length of stay

Number of days that each patient spends in ICU

Hospital length of stay

Number of days that each patients spends in hospital

Duration of non-invasive ventilation

Number of days that patient receives non-invasive ventilation

Duration of invasive ventilation

Number of days that patient receives invasive ventilation

Adverse events

Any complications related to NIV use

Comfort

Patient comfort with non-invasive ventilation

Full Information

NCT ID

NCT05022173

First Posted

July 26, 2021

Last Updated

March 8, 2023

Sponsor

Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05022173

Brief Title

Helmet NIV in Acute Respiratory Failure

Acronym

HELMET

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 11, 2021 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hamilton Health Sciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Failure

Keywords

non-invasive ventilation, Helmet non-invasive ventilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Helmet NIV

Arm Type

Experimental

Arm Description

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.

Arm Title

Facemask NIV

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Helmet Non-Invasive Ventilation

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Facemask Non-Invasive Ventilation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Consent Rate

Description

Percentage of patients or SDMs approached for consent who give consent

Time Frame

1 year

Title

Recruitment Rate

Description

Number of patients recruited to the study per centre

Time Frame

1 year

Title

Protocol adherence percentage

Description

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.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Endotracheal intubation

Description

Number of patients requiring endotracheal intubation

Time Frame

28 days

Title

ICU mortality

Description

Number of patients who die in ICU

Time Frame

28 days

Title

Hospital mortality

Description

Number of patients who die in hospital

Time Frame

60 days

Title

ICU length of stay

Description

Number of days that each patient spends in ICU

Time Frame

Censored at 28 days

Title

Hospital length of stay

Description

Number of days that each patients spends in hospital

Time Frame

Censored at 60 days

Title

Duration of non-invasive ventilation

Description

Number of days that patient receives non-invasive ventilation

Time Frame

Censored at 28 days

Title

Duration of invasive ventilation

Description

Number of days that patient receives invasive ventilation

Time Frame

Censored at 28 days

Title

Adverse events

Description

Any complications related to NIV use

Time Frame

28 days

Title

Comfort

Description

Patient comfort with non-invasive ventilation

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dipayan Chaudhuri, MD

Phone

9055212100

dipayan.chaudhuri@medportal.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bram Rochwerg, MD

Organizational Affiliation

Hamilton Health Science

Official's Role

Principal Investigator

Facility Information:

Facility Name

Juravinski Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V1C3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dipayan Chaudhuri, MD

dipayan_c@hotmail.com

First Name & Middle Initial & Last Name & Degree

Bram Rochwerg, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Helmet NIV in Acute Respiratory Failure

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