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Respiratory Support
HFNO With or Without Helmet NIV for Hypoxemic Respiratory Failure (HONOUR Trial)
N/A
Recruiting
Led By Damon Scales, MD PhD FRCPC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
HONOUR Trial Summary
This trial will compare the effects of two treatments for people with AHRF. One treatment is helmet NIV combined with HFNO, and the other is HFNO alone.
Who is the study for?
This trial is for adults in the ICU with low oxygen levels despite receiving a moderate amount of oxygen, who have been experiencing acute respiratory failure for at least an hour. It's not suitable for those with neuromuscular diseases, recent trauma preventing helmet use, or conditions that make positive pressure to the face risky. Patients already on high-flow oxygen or needing immediate intubation are excluded.Check my eligibility
What is being tested?
The study compares two ways to help patients breathe: one group will receive high flow nasal oxygen (HFNO) alone, and another will get HFNO combined with a special helmet that supports breathing without needing a tube in the windpipe. Participants are randomly assigned to either method.See study design
What are the potential side effects?
Possible side effects include discomfort from wearing the equipment, skin irritation around where the devices contact the face, dryness or bleeding of nose/mouth/throat due to airflow, and potential lung injury if pressures are too high.
HONOUR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence/Compliance to Oxygenation Strategy
Intubation (procedure)
Non-randomized Eligible Patients
+2 moreSecondary outcome measures
Activities of Daily Living
All cause mortality
COVID-19 infection after hospitalization
+7 moreHONOUR Trial Design
2Treatment groups
Active Control
Group I: H-NIVActive Control1 Intervention
Helmet Non-Invasive ventilation for a minimum of 12 hours per day with HFNO between sessions
Group II: HFNOActive Control1 Intervention
High Flow Nasal Oxygen alone
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,422 Total Patients Enrolled
Damon Scales, MD PhD FRCPCPrincipal InvestigatorSunnybrook Health Sciences Centre
1 Previous Clinical Trials
2,040 Total Patients Enrolled
Niall Fergusson, MD FRCPCPrincipal InvestigatorUniversity Health Network, Toronto
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known neuromuscular disease.You have been using high-flow nasal oxygen or other non-invasive ventilation with high oxygen levels for the past 24 hours in the intensive care unit.You need to be intubated right away because you are having trouble breathing or have a serious lung or heart problem.You are not expected to live longer than 24 hours or are moving to palliative care.Your doctor has decided that using positive pressure on your face or nasal area is not safe for you due to a medical procedure or injury.Your blood oxygen level is lower than 98% when you are using a high level of oxygen support.If there is no test for the amount of oxygen and carbon dioxide in your blood, then the ratio of oxygen in your blood to the amount of oxygen you are breathing is less than 315.You have injuries that make it unsafe for you to wear the helmet, such as a neck brace or upper body fractures.You were removed from a breathing tube in the intensive care unit within the last 72 hours.Your doctor believes that you need to use a face mask with non-invasive ventilation to treat severe breathing or heart problems.You have had difficulty breathing and low oxygen levels for at least 1 hour, and you still have these symptoms when being checked for eligibility for the study.You breathe more than 21 times per minute or show signs of struggling to breathe.You have been diagnosed with low oxygen levels in your blood.Your blood oxygen level is too low compared to the amount of oxygen you are breathing in.
Research Study Groups:
This trial has the following groups:- Group 1: H-NIV
- Group 2: HFNO
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are undertaking this clinical research?
"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial is open for recruitment, which began on March 17th 2022 and had its last update on April 26th 2022. The study aims to include 200 participants from 3 different medical facilities in the experiment."
Answered by AI
Are additional participants being accepted for this clinical research?
"The listing on clinicaltrials.gov confirms that this trial is open to recruitment, with the initial posting date of March 17th 2022 and a recent update on April 26th 2022."
Answered by AI
What are the key goals of this research initiative?
"This two-year medical trial seeks to evaluate the number of participants requiring intubation in each group based on pre-determined criteria. Secondary objectives include assessing duration of non-invasive respiratory support, non-invasive mechanical ventilation, and invasive mechanical ventilation up to 28 or 60 days post randomization."
Answered by AI
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