HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT

Acute Hypoxemic Respiratory Failure Clinical Trial

— HONOUR  

Official title:

High-flow Nasal Oxygen With or Without Helmet Non-invasive Ventilation for Oxygenation Support in Acute Respiratory Failure (the HONOUR Pilot Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078034
• Other study ID #: HONOUR (3693)
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: April 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: Damon Scales, MD PhD FRCPC
• Phone: 416-480-5291
• Email: damon.scales[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Randomized Control Trial will directly compare helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) versus HFNO alone in patients with Acute Hypoxemic Respiratory Failure (AHRF).

Description:

This is a pilot multicentre, concealed, stratified, permuted block randomized controlled trial enrolling patients with AHRF who are admitted to the intensive care unit. Patients with imminent need for intubation, or a contraindication to study interventions will be excluded. Patients will be randomized to receive either (1) sessions of at least 12 hours per day of helmet NIV oxygen interspersed with HFNO or (2) HFNO alone over at least 2 calendar days. Participants will be followed to hospital discharge or 60 days, with an additional quality of life assessment via telephone interview 6 months after enrolment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Intensive care unit admission (orders written)

2. Age =18 years

3. Hypoxemic acute respiratory failure for at least 1 hour and still present at time of screening for eligibility (symptom onset during last 14 days) with the following:

1. Respiratory rate >21bpm or clinical evidence of increased work of breathing and

2. Documented Hypoxemia defined as any one of:

i. PaO2:FiO2 < 300 ii. If no arterial blood gas available, then SpO2:FiO2 < 315 iii. Oxygen saturation <98% on FiO2 >= 0.4 or higher by Venturi mask, TAVISH mask 10 Litres / minute, or any non-invasive oxygenation strategy

4. Not already intubated or with tracheostomy

Exclusion Criteria:

1. Already on HFNO or other non-invasive ventilation strategy at FiO2>=0.4 for the last 24 hours in the ICU.

2. Immediate need for intubation (e.g., inadequate airway protection or refractory hypoxemia or cardiopulmonary arrest, massive hemoptysis, etc)

3. Extubated in the ICU within past 72 hours

4. Clinician deems that face mask NIV is indicated to treat a primary diagnosis of hypercapnic respiratory failure or acute congestive heart failure

5. Known neuromuscular disease

6. Patients being transitioned to Palliative care or unlikely to survive more than 24 hours

7. ICU discharge is planned or anticipated on the day of screening

8. Previously enrolled in this trial

9. Trauma patients who remain in a cervical spine collar at the time of recruitment or who have upper limb/torso fractures that would preclude them from safe application of the helmet

10. Clinician decision that positive pressure to face and/or nasal pharynx is a contraindication (eg. Transphenoidal surgery, basal skull fracture etc.)

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Helmet Non-Invasive Ventilation (HNIV)
HNIV will be connected to a ventilator by a conventional closed respiratory circuit. Sessions of HNIV will be delivered with PEEP targeting a minimum 12 hours/day. PEEP will be titrated according to patient comfort, work of breathing, and O2 saturation. Pressure support will be titrated to lowest level tolerated. Between HNIV sessions, patients will be supported with HFNO at the same required FiO2. Starting on study day 3, patients will be screened for discontinuation of HNIV. Once HNIV is stopped, patients will be transitioned to HFNO and then weaned from HFNO as tolerated.
• High Flow Nasal Oxygen
HFNO will be provided. FiO2 will be titrated to achieve a target O2 saturation of 92-97%, and flows will be initiated at 50 litres/minute and titrated as per usual practice for comfort and oxygenation. Once the target O2 saturation is achieved, the FiO2 will be titrated to the minimal value to maintain this target saturation. HFNO will be provided continuously over a minimum of 2 calendar days. Starting on study day 3, patients will be weaned from HFNO as tolerated.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Sciences- Juravinski	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	North York General Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network Toronto General	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rates	Recruitment rate at different study sites	2 years
Primary	Non-randomized Eligible Patients	Proportion of Eligible patients who are not randomized and reasons for this	2 years
Primary	Adherence/Compliance to Oxygenation Strategy	Rate of adherence to the assigned oxygenation strategy (and crossover rates)	2 years
Primary	Among patients requiring intubation in each group, the number who were intubated according to the pre-specified criteria	Adherence to pre-specified criteria for intubation in each group	2 years
Primary	Time from ICU admission to randomization and initiation of treatment	Median time from ICU admission to randomization and initiation of the allocated treatment	2 years
Secondary	Number of participants in each group who need endotracheal intubation	Need for endotracheal intubation after randomization	28 and 60 days
Secondary	Duration of invasive mechanical ventilation after randomization up to 28 and 60 days	Duration of invasive mechanical ventilation after randomization up to 28 and 60 days	28 and 60 days
Secondary	Duration of non-invasive respiratory support after randomization up to 28 and 60 days	Duration of non-invasive mechanical ventilation after randomization up to 60 days	60 days
Secondary	ICU length of stay	days of ICU up to 28 days after randomization	28 days
Secondary	All cause mortality	All cause mortality to 60 days	60 days
Secondary	COVID-19 infection after hospitalization	diagnosis of COVID-19	28 days
Secondary	Health related quality of life	Health related quality of life as measured by telephone using the European Quality of Life Five Dimension (EQ-5D) tool, where a score of 1 means the patient has no problems, and a score of 5 mean the patient has extreme problems in the 5 dimensions.	180 days
Secondary	Mortality at 180 days	Mortality to 180 days	180 days
Secondary	Activities of Daily Living	Katz Index of Independence in Activities of Daily Living (ADL) where a high of 6 means the patient can perform the activities fully independently, and a low of 0 means the patient is fully dependent and unable to perform activities without assistance.	180 days
Secondary	Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days	Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days	28 days