Cough Determinants in Mechanically Ventilated Patients
Extu-Cough
1 other identifier
interventional
180
1 country
2
Brief Summary
In our knowledge there is only few data about the cough determinants in mechanically ventilated patients. However some failure of extubation is due to inefficiency cough. In order to determine some determinants of cough, the investigators propose to evaluate systematically different physiological parameters before and after extubation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 25, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 22, 2019
February 1, 2014
3.8 years
March 25, 2012
April 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Interest of systematically cough evaluation before extubation
All the patients enrolled have a physiological evaluation before and after extubation. After extubation the evaluation will be done respectively at D0, D1, D3 and D5. The first endpoint is the success of extubation which is evaluated à D2.
2 days after extubation
Secondary Outcomes (1)
Correlation between success of extubation and respiratory parameters
2 days after extubation
Study Arms (1)
Cough Determinants
OTHERInterventions
Each enrolled patients has a pulmonary function test before and after extubation, and repeatedly at D1, D3, D5 (if they are always hospitalized)
Eligibility Criteria
You may qualify if:
- Patients mechanically ventilated since 72h
- Age \> 18 years
- Hospitalized in Intensive care Unit
- In weaning phase - with the classically criteria to be extubated
- Patients who passed the weaning test (T tube test or other)
You may not qualify if:
- Hemodynamic instability
- Absence of consent
- No cooperation of the patient
- Hemodynamic instability
- pH \< 7,30
- Severe hypoxemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital, Caen
Caen, 1400, France
University Hospital, Garches
Garches, 92380, France
Related Publications (1)
Terzi N, Lofaso F, Masson R, Beuret P, Normand H, Dumanowski E, Falaize L, Sauneuf B, Daubin C, Brunet J, Annane D, Parienti JJ, Orlikowski D. Physiological predictors of respiratory and cough assistance needs after extubation. Ann Intensive Care. 2018 Feb 5;8(1):18. doi: 10.1186/s13613-018-0360-3.
PMID: 29404723DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas TERZI, MD - PhD
University Hospital, Caen
- PRINCIPAL INVESTIGATOR
Frédéric Lofaso, MD-PhD
University Hospital, Garches
- PRINCIPAL INVESTIGATOR
David Orlikowski, MD-PhD
University Hospital, Garches
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2012
First Posted
March 28, 2012
Study Start
March 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 22, 2019
Record last verified: 2014-02