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Non-Invasive Ventilation

Helmet vs Facemask Ventilation for Acute Respiratory Failure (HELMET Trial)

N/A
Recruiting
Led By Bram Rochwerg, MD
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

HELMET Trial Summary

This trial will compare two methods of non-invasive ventilation to see if one is better than the other at reducing mortality in patients with sudden respiratory failure.

Who is the study for?
This trial is for adults in the ICU who need non-invasive ventilation (NIV) due to sudden respiratory failure. It's not for those who use NIV regularly, have severe consciousness impairment (Glasgow coma scale <9), airway issues, are at risk of cardiac arrest or refuse intubation, have facial trauma, can't wear the equipment properly, or have certain untreated conditions like high brain pressure or pneumothorax.Check my eligibility
What is being tested?
The study is testing if a new type of NIV called 'helmet' is better than the traditional face mask in helping patients with acute respiratory failure and preventing death. The goal is to see if it's feasible to do a larger study on this topic.See study design
What are the potential side effects?
Potential side effects may include discomfort wearing the devices, skin breakdown from prolonged contact with helmet or facemask edges, eye irritation from exhaled air directed towards eyes in some mask designs, and possibly claustrophobia with helmet use.

HELMET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Consent Rate
Protocol adherence percentage
Recruitment Rate
Secondary outcome measures
Adverse events
Comfort
Duration of invasive ventilation
+6 more

HELMET Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Helmet NIVExperimental Treatment1 Intervention
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.
Group II: Facemask NIVActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,986 Total Patients Enrolled
Bram Rochwerg, MDPrincipal InvestigatorHamilton Health Science

Media Library

Facemask NIV (Non-Invasive Ventilation) Clinical Trial Eligibility Overview. Trial Name: NCT05022173 — N/A
Acute Respiratory Failure Research Study Groups: Helmet NIV, Facemask NIV
Acute Respiratory Failure Clinical Trial 2023: Facemask NIV Highlights & Side Effects. Trial Name: NCT05022173 — N/A
Facemask NIV (Non-Invasive Ventilation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05022173 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Helmet NIV in Acute Respiratory Failure
2021. "Helmet NIV in Acute Respiratory Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05022173.
~0 spots leftby Jun 2024
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