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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02123940 |
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Date of registration:
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11/04/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment Strategy in Patients With High-risk of Postextubation Distress in ICU Based on a Lung Ultrasound Score Versus Standard Strategy
WIN IN WEAN |
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Scientific title:
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Treatment Strategy in Patients With High-risk of Postextubation Distress in ICU Based on a Lung Ultrasound Score Versus Standard Strategy |
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Date of first enrolment:
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February 2014 |
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Target sample size:
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483 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02123940 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Sébastien PERBET |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Clermont-Ferrand |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients ventilated more than 48 h
- Stable respiratory and hemodynamic conditions for SBT
- Consent of patients
- Arterial line
Exclusion Criteria:
- severe COBP
- Laryngeal dyspnea
- Tracheostomy
- Arrhythmia
- No echogenicity
- Paraplegia >T8
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Adult Patients Ventilated More Than 48 h
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Intervention(s)
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Device: lung ultrasound score
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Primary Outcome(s)
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Incidence of postextubation distress
[Time Frame: during 48 hour (at day 1)]
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Secondary Outcome(s)
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Length of stay in ICU
[Time Frame: at day 1]
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Number of ventilator-free-days
[Time Frame: at day 1 (after extubation)]
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Extubation failure
[Time Frame: at day 7]
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Mortality in ICU
[Time Frame: at day 1]
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Secondary ID(s)
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2013-A01458-37
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CHU-0187
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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