NCT02123940

Brief Summary

Prospective, randomized clinical multicentric study in ICU during weaning from mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2018

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

April 11, 2014

Last Update Submit

April 16, 2026

Conditions

Adult Patients Ventilated More Than 48 h

Keywords

Weaning from mechanical ventilationLung ultrasoundNasal humidified high flow therapyWeaning failurePostextubation distress

Outcome Measures

Primary Outcomes (1)

  • Incidence of postextubation distress

    postextubation period requiring a ventilatory support (reintubation or curative Noninvasive ventilation).

    during 48 hour (at day 1)

Secondary Outcomes (4)

  • Number of ventilator-free-days

    at day 1 (after extubation)

  • Length of stay in ICU

    at day 1

  • Mortality in ICU

    at day 1

  • Extubation failure

    at day 7

Study Arms (2)

nasal humidified high flow therapy

EXPERIMENTAL

Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy

Device: lung ultrasound score

standard strategy

OTHER

Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy

Device: lung ultrasound score

Interventions

lung ultrasound scoreDEVICE

Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy

nasal humidified high flow therapystandard strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients ventilated more than 48 h
  • Stable respiratory and hemodynamic conditions for SBT
  • Consent of patients
  • Arterial line

You may not qualify if:

  • severe COBP
  • Laryngeal dyspnea
  • Tracheostomy
  • Arrhythmia
  • No echogenicity
  • Paraplegia \>T8

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Rouby JJ, Perbet S, Quenot JP, Zhang M, Andreu P, Assefi M, Gao Y, Deransy R, Lyu J, Arbelot C, An Y, Monsel A, Jing X, Guerci P, Qian C, Malbouisson L, Morand D, Puybasset L, Futier E, Constantin JM, Pereira B; WIN IN WEAN Study Group. Weaning of non COPD patients at high-risk of extubation failure assessed by lung ultrasound: the WIN IN WEAN multicentre randomised controlled trial. Crit Care. 2024 Nov 26;28(1):391. doi: 10.1186/s13054-024-05166-w.

    PMID: 39593129RESULT

Study Officials

  • Sébastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2014

First Posted

April 28, 2014

Study Start

February 1, 2014

Primary Completion

August 25, 2018

Study Completion

August 25, 2018

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

FR(1)