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

Primary Purpose

Acute Hypoxemic Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Helmet Non-Invasive Ventilation (HNIV)
High Flow Nasal Oxygen
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypoxemic Respiratory Failure focused on measuring High Flow Nasal Oxygen, Helmet Non Invasive Ventilation

Eligibility Criteria

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

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

b. 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

Exclusion Criteria:

  1. Patients who are intubated or with tracheostomy
  2. Already on HFNO or other non-invasive oxygenation strategy at FiO2>=0.4 for the last 18 hours
  3. Immediate need for intubation (e.g., inadequate airway protection or refractory hypoxemia or cardiopulmonary arrest, massive hemoptysis, etc)
  4. Extubated in the ICU within past 72 hours
  5. Clinician deems that face mask NIV is indicated to treat a primary diagnosis of acute exacerbation of chronic hypercapnic respiratory failure or acute congestive heart failure
  6. Known neuromuscular disease
  7. Patients being transitioned to Palliative care or unlikely to survive more than 24 hours
  8. ICU discharge is planned or anticipated on the day of screening
  9. Previously enrolled in this trial
  10. 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 .
  11. Clinician decision that positive pressure to face and/or nasal pharynx is a contraindication (ie. Transphenoidal surgery etc.)

Sites / Locations

  • Hamilton Health Sciences- JuravinskiRecruiting
  • Kingston General HospitalRecruiting
  • London Health Sciences CentreRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • Mount Sinai HospitalRecruiting
  • University Health Network Toronto GeneralRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HFNO

H-NIV

Arm Description

High Flow Nasal Oxygen alone

Helmet Non-Invasive ventilation for a minimum of 12 hours per day with HFNO between sessions

Outcomes

Primary Outcome Measures

Recruitment Rates
Recruitment rate at different study sites
Non-randomized Eligible Patients
Proportion of Eligible patients who are not randomized and reasons for this
Adherence/Compliance to Oxygenation Strategy
Rate of adherence to the assigned oxygenation strategy (and crossover rates)
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
Time from ICU admission to randomization and initiation of treatment
Median time from ICU admission to randomization and initiation of the allocated treatment

Secondary Outcome Measures

Number of participants in each group who need endotracheal intubation
Need for endotracheal intubation after randomization
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
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
ICU length of stay
days of ICU up to 28 days after randomization
All cause mortality
All cause mortality to 60 days
COVID-19 infection after hospitalization
diagnosis of COVID-19
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.
Mortality at 180 days
Mortality to 180 days
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.
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

Full Information

First Posted
October 1, 2021
Last Updated
February 10, 2023
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05078034
Brief Title
HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypoxemic Respiratory Failure
Keywords
High Flow Nasal Oxygen, Helmet Non Invasive Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HFNO
Arm Type
Active Comparator
Arm Description
High Flow Nasal Oxygen alone
Arm Title
H-NIV
Arm Type
Active Comparator
Arm Description
Helmet Non-Invasive ventilation for a minimum of 12 hours per day with HFNO between sessions
Intervention Type
Device
Intervention Name(s)
Helmet Non-Invasive Ventilation (HNIV)
Other Intervention Name(s)
HNIV
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Oxygen
Other Intervention Name(s)
HFNO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Rates
Description
Recruitment rate at different study sites
Time Frame
2 years
Title
Non-randomized Eligible Patients
Description
Proportion of Eligible patients who are not randomized and reasons for this
Time Frame
2 years
Title
Adherence/Compliance to Oxygenation Strategy
Description
Rate of adherence to the assigned oxygenation strategy (and crossover rates)
Time Frame
2 years
Title
Among patients requiring intubation in each group, the number who were intubated according to the pre-specified criteria
Description
Adherence to pre-specified criteria for intubation in each group
Time Frame
2 years
Title
Time from ICU admission to randomization and initiation of treatment
Description
Median time from ICU admission to randomization and initiation of the allocated treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of participants in each group who need endotracheal intubation
Description
Need for endotracheal intubation after randomization
Time Frame
28 and 60 days
Title
Duration of invasive mechanical ventilation after randomization up to 28 and 60 days
Description
Duration of invasive mechanical ventilation after randomization up to 28 and 60 days
Time Frame
28 and 60 days
Title
Duration of non-invasive respiratory support after randomization up to 28 and 60 days
Description
Duration of non-invasive mechanical ventilation after randomization up to 60 days
Time Frame
60 days
Title
ICU length of stay
Description
days of ICU up to 28 days after randomization
Time Frame
28 days
Title
All cause mortality
Description
All cause mortality to 60 days
Time Frame
60 days
Title
COVID-19 infection after hospitalization
Description
diagnosis of COVID-19
Time Frame
28 days
Title
Health related quality of life
Description
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.
Time Frame
180 days
Title
Mortality at 180 days
Description
Mortality to 180 days
Time Frame
180 days
Title
Activities of Daily Living
Description
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.
Time Frame
180 days
Title
Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days
Description
Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intensive care unit admission (orders written) Age ≥18 years 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: Respiratory rate >21bpm or clinical evidence of increased work of breathing and 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 Not already intubated or with tracheostomy Exclusion Criteria: Already on HFNO or other non-invasive ventilation strategy at FiO2>=0.4 for the last 24 hours in the ICU. Immediate need for intubation (e.g., inadequate airway protection or refractory hypoxemia or cardiopulmonary arrest, massive hemoptysis, etc) Extubated in the ICU within past 72 hours Clinician deems that face mask NIV is indicated to treat a primary diagnosis of hypercapnic respiratory failure or acute congestive heart failure Known neuromuscular disease Patients being transitioned to Palliative care or unlikely to survive more than 24 hours ICU discharge is planned or anticipated on the day of screening Previously enrolled in this trial 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 Clinician decision that positive pressure to face and/or nasal pharynx is a contraindication (eg. Transphenoidal surgery, basal skull fracture etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damon Scales, MD PhD FRCPC
Phone
416-480-5291
Email
damon.scales@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Project Manager
Phone
416-480-6100
Ext
87535
Email
HONOUR@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damon Scales, MD PhD FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niall Fergusson, MD FRCPC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences- Juravinski
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bram Rochwerg, MD
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Muscedere, MD
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marat Slessarev, MD
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damon Scales, MD
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laveena Munshi, MD
Facility Name
University Health Network Toronto General
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Del Sorbo, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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