Back to results

High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period (HIGH-WEAN)

Primary Purpose

Acute Respiratory Failure Requiring Reintubation

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

HFNC

NIV

About this trial

This is an interventional treatment trial for Acute Respiratory Failure Requiring Reintubation

Eligibility Criteria

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

Inclusion Criteria:

Duration of mechanical ventilation prior to extubation at least 24h
Planned extubation decided by the physician in charge of the patient after success of a weaning trial
Patients at high risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease.

Exclusion Criteria:

Patient admitted for traumatic brain injury
Periphal neuromuscular disease as reason for intubation
Usual lon-term treatment with NIV for chronic desease
Usual lon-term treatment with CPAP for obstructive apneas syndrome
Contraindication to NIV
Unplanned extubation
Do-not-reintubated order at time of extubation
Terminal extubation for end of life
People under legal protection
Opposition to participate

Sites / Locations

CHU Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HFNC alone

HFNC and NIV

Arm Description

Control group

Outcomes

Primary Outcome Measures

Reintubation at Day 7

The rate of reintubation will be assessed within the 7 days following planned extubation

Secondary Outcome Measures

Full Information

NCT ID

NCT03121482

First Posted

March 23, 2017

Last Updated

March 11, 2019

Sponsor

Poitiers University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03121482

Brief Title

High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period

Acronym

HIGH-WEAN

Official Title

High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

April 20, 2017 (Actual)

Primary Completion Date

April 17, 2018 (Actual)

Study Completion Date

April 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Failure Requiring Reintubation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

650 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HFNC alone

Arm Type

Active Comparator

Arm Description

Control group

Arm Title

HFNC and NIV

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

HFNC

Intervention Description

Gas flow of 50 l/min and FiO2 adjusted to obtain SpO2 ≥ 92%

Intervention Type

Device

Intervention Name(s)

NIV

Intervention Description

Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cm H2O with FiO2 adjusted to obtain SpO2 ≥ 92%

Primary Outcome Measure Information:

Title

Reintubation at Day 7

Description

The rate of reintubation will be assessed within the 7 days following planned extubation

Time Frame

up to 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Duration of mechanical ventilation prior to extubation at least 24h Planned extubation decided by the physician in charge of the patient after success of a weaning trial Patients at high risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease. Exclusion Criteria: Patient admitted for traumatic brain injury Periphal neuromuscular disease as reason for intubation Usual lon-term treatment with NIV for chronic desease Usual lon-term treatment with CPAP for obstructive apneas syndrome Contraindication to NIV Unplanned extubation Do-not-reintubated order at time of extubation Terminal extubation for end of life People under legal protection Opposition to participate

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnaud W THILLE

Organizational Affiliation

CHU Poitiers

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Poitiers

City

Poitiers

ZIP/Postal Code

86000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34813391

Citation

Thille AW, Coudroy R, Nay MA, Gacouin A, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouze A, Vivier E, Lascarrou JB, Ricard JD, Mekontso-Dessap A, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Frat JP, Ragot S; HIGH-WEAN Study Group and the REVA Research Network. Beneficial Effects of Noninvasive Ventilation after Extubation in Obese or Overweight Patients: A Post Hoc Analysis of a Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Feb 15;205(4):440-449. doi: 10.1164/rccm.202106-1452OC.

Results Reference

derived

PubMed Identifier

34183053

Citation

Thille AW, Monseau G, Coudroy R, Nay MA, Gacouin A, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouze A, Vivier E, Lascarrou JB, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA research network. Non-invasive ventilation versus high-flow nasal oxygen for postextubation respiratory failure in ICU: a post-hoc analysis of a randomized clinical trial. Crit Care. 2021 Jun 28;25(1):221. doi: 10.1186/s13054-021-03621-6.

Results Reference

derived

PubMed Identifier

33559765

Citation

Thille AW, Coudroy R, Nay MA, Gacouin A, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouze A, Vivier E, Lascarrou JB, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group, for the REVA Research Network. Non-invasive ventilation alternating with high-flow nasal oxygen versus high-flow nasal oxygen alone after extubation in COPD patients: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Feb 9;11(1):30. doi: 10.1186/s13613-021-00823-7.

Results Reference

derived

PubMed Identifier

31577036

Citation

Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901. Erratum In: JAMA. 2020 Feb 25;323(8):793.

Results Reference

derived

PubMed Identifier

30185583

Citation

Thille AW, Muller G, Gacouin A, Coudroy R, Demoule A, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Picard W, Bourenne J, Pradel G, Bailly P, Terzi N, Buscot M, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Ragot S, Frat JP; REVA research network. High-flow nasal cannula oxygen therapy alone or with non-invasive ventilation during the weaning period after extubation in ICU: the prospective randomised controlled HIGH-WEAN protocol. BMJ Open. 2018 Sep 5;8(9):e023772. doi: 10.1136/bmjopen-2018-023772.

Results Reference

derived

Learn more about this trial

High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period

We'll reach out to this number within 24 hrs