Helmet NIV in Acute Respiratory Failure

Acute Respiratory Failure Clinical Trial

— HELMET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05022173
• Other study ID #: 13412
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: November 2024

Study information

• Verified date: March 2023
• Source: Hamilton Health Sciences Corporation
• Contact: Dipayan Chaudhuri, MD
• Phone: 9055212100
• Email: dipayan.chaudhuri[@]medportal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Juravinski Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consent Rate	Percentage of patients or SDMs approached for consent who give consent	1 year
Primary	Recruitment Rate	Number of patients recruited to the study per centre	1 year
Primary	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	Endotracheal intubation	Number of patients requiring endotracheal intubation	28 days
Secondary	ICU mortality	Number of patients who die in ICU	28 days
Secondary	Hospital mortality	Number of patients who die in hospital	60 days
Secondary	ICU length of stay	Number of days that each patient spends in ICU	Censored at 28 days
Secondary	Hospital length of stay	Number of days that each patients spends in hospital	Censored at 60 days
Secondary	Duration of non-invasive ventilation	Number of days that patient receives non-invasive ventilation	Censored at 28 days
Secondary	Duration of invasive ventilation	Number of days that patient receives invasive ventilation	Censored at 28 days
Secondary	Adverse events	Any complications related to NIV use	28 days
Secondary	Comfort	Patient comfort with non-invasive ventilation	28 days