Adult Patients Ventilated More Than 48 hPhase 3WIN IN WEANNCT02123940
Treatment Strategy in Patients With High-risk of Postextubation Distress in ICU Based on a Lung Ultrasound Score Versus Standard Strategy
A Phase 3 study testing lung ultrasound score in people with Adult Patients Ventilated More Than 48 h, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Prospective, randomized clinical multicentric study in ICU during weaning from mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients Ventilated More Than 48 h
- What is being tested?
- lung ultrasound score
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 483 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to 25 Aug 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ventilated more than 48 h
- Stable respiratory and hemodynamic conditions for SBT
- Consent of patients
- Arterial line
Who cannot join
- severe COBP
- Laryngeal dyspnea
- Tracheostomy
- Arrhythmia
- No echogenicity
- Paraplegia >T8
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, randomized clinical multicentric study in ICU during weaning from mechanical ventilation.
Read the detailed description
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
- Conditions
- Adult Patients Ventilated More Than 48 h
- Being tested
- lung ultrasound score
- Keywords
- Weaning from mechanical ventilation, Lung ultrasound, Nasal humidified high flow therapy, Weaning failure, Postextubation distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: lung ultrasound score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postextubation distress
postextubation period requiring a ventilatory support (reintubation or curative Noninvasive ventilation).
Measured: during 48 hour (at day 1)
Secondary outcomes (4)
Number of ventilator-free-days
Measured: at day 1 (after extubation)
Length of stay in ICU
Measured: at day 1
Mortality in ICU
Measured: at day 1
Extubation failure
Extubation failure within the 7 days following planned extubation
Measured: at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completion25 Aug 2018
- Study completion25 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Patients Ventilated More Than 48 hStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital, University Hospital, Grenoble, Hospices Civils de Lyon, Centre Hospitalier Universitaire de Saint Etienne, University Hospital, Marseille
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123940
- Sponsor's protocol ID
- CHU-0187
- Other IDs
- 2013-A01458-37
- Acronym
- WIN IN WEAN
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2014
- Last updated
- 21 Apr 2026
- Results posted
- No
Publications
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.
PubMed 39593129
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Strategy in Patients With High-risk of Postextubation Distress in ICU Based on a Lung Ultrasound Score Versus Standard Strategy
- ClinicalTrials.gov ID
- NCT02123940
- Acronym / sponsor ID
- WIN IN WEAN / CHU-0187
- Conditions
- Adult Patients Ventilated More Than 48 h
- Keywords
- Weaning from mechanical ventilation, Lung ultrasound, Nasal humidified high flow therapy, Weaning failure, Postextubation distress
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital, University Hospital, Grenoble, Hospices Civils de Lyon, Centre Hospitalier Universitaire de Saint Etienne, University Hospital, Marseille
- Study start
- Feb 2014 (actual)
- Primary completion
- 25 Aug 2018 (actual)
- Study completion
- 25 Aug 2018 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, randomized clinical multicentric study in ICU during weaning from mechanical ventilation.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal humidified high flow therapy | Experimental | Device: lung ultrasound scoreProspective 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 |
| standard strategy | Other | Device: lung ultrasound scoreProspective 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients ventilated more than 48 h
- Stable respiratory and hemodynamic conditions for SBT
- Consent of patients
- Arterial line
Key exclusion criteria (6 listed)
- severe COBP
- Laryngeal dyspnea
- Tracheostomy
- Arrhythmia
- No echogenicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung ultrasound scoreProspective 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 | nasal humidified high flow therapy, standard strategy |
Primary outcome
Incidence of postextubation distress
Time frame: during 48 hour (at day 1)
postextubation period requiring a ventilatory support (reintubation or curative Noninvasive ventilation).
4 secondary outcomes
Number of ventilator-free-days
Time frame: at day 1 (after extubation)
Length of stay in ICU
Time frame: at day 1
Mortality in ICU
Time frame: at day 1
Extubation failure
Time frame: at day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 39593129Rouby 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien PERBET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lung ultrasound score in people with Adult Patients Ventilated More Than 48 h, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postextubation distress (time frame: during 48 hour (at day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.