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

NCT03121482 | Completed

• 2 other identifiers: HIGH-WEAN Study2016-A01078-43
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure Requiring Reintubation

Outcome Measures

Primary Outcomes (1)

• Reintubation at Day 7

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

  up to 7 days

Study Arms (2)

HFNC alone

ACTIVE COMPARATOR

Control group

Device: HFNC

HFNC and NIV

EXPERIMENTAL

Device: HFNC; Device: NIV

Interventions

HFNC DEVICE

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

HFNC alone; HFNC and NIV

NIV DEVICE

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%

HFNC and NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

Location

Related Publications (5)

• 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.

  PMID: 34813391 DERIVED

• 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.

  PMID: 34183053 DERIVED

• 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.

  PMID: 33559765 DERIVED

• 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.

  PMID: 31577036 DERIVED

• 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.

  PMID: 30185583 DERIVED

Study Officials

• Arnaud W THILLE

  CHU Poitiers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 20, 2017
• Study Start: April 20, 2017
• Primary Completion: April 17, 2018
• Study Completion: April 17, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)