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Cough Determinants in Mechanically Ventilated Patients (Extu-Cough)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Nicolas TERZI, University Hospital, Caen.
Recruitment status was:  Recruiting
INSERM U1075,Caen
Centre d'Investigation Clinique et Technologique 805
Information provided by (Responsible Party):
Nicolas TERZI, University Hospital, Caen Identifier:
First received: March 25, 2012
Last updated: February 3, 2014
Last verified: February 2014
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.

Condition Intervention
Mechanical Ventilation Other: Functional respiratory evaluation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cough Determinants in Mechanically Ventilated Patients: a Physiological Study

Resource links provided by NLM:

Further study details as provided by Nicolas TERZI, University Hospital, Caen:

Primary Outcome Measures:
  • Interest of systematically cough evaluation before extubation [ Time Frame: 2 days after 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.

Secondary Outcome Measures:
  • Correlation between success of extubation and respiratory parameters [ Time Frame: 2 days after extubation ]

Estimated Enrollment: 180
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Cough Determinants Other: Functional respiratory evaluation
Each enrolled patients has a pulmonary function test before and after extubation, and repeatedly at D1, D3, D5 (if they are always hospitalized)
Other Name: Pulmonary Function test

Detailed Description:
In order to evaluate, and identify the cough determinants, the investigators propose a physiological evaluation for each patients who were intubated and mechanically ventilated during at least 72 hours. Indeed inefficacy of cough after extubation is one of the main reason of extubation failure. However there is no any mean to evaluate it simply now.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Hemodynamic instability
  • Absence of consent
  • No cooperation of the patient
  • Hemodynamic instability
  • pH < 7,30
  • Severe hypoxemia
  Contacts and Locations
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Please refer to this study by its identifier: NCT01564745

Contact: Nicolas TERZI, MD - PhD +33231065268

University Hospital, Caen Recruiting
Caen, France, 1400
Contact: Nicolas TERZI, MD - PhD    +33231065268   
Sub-Investigator: Damien Du CHEYRON, MD-PhD         
Sub-Investigator: Cedric DAUBIN, MD         
Sub-Investigator: Romain MASSON, MD         
Sub-Investigator: Bertrand SAUNEUF, MD         
Sub-Investigator: Amelie SEGUIN, MD         
Sub-Investigator: Xavier VALETTE, MD         
University Hospital, Garches Recruiting
Garches, France, 92380
Contact: Frédéric LOFASO, MD-PhD   
Principal Investigator: Djillali ANNANE, MD-PhD         
Principal Investigator: David ORLIKOWSKI, MD-PhD         
Sub-Investigator: Hélène PRIGENT, MD-PhD         
Sponsors and Collaborators
University Hospital, Caen
INSERM U1075,Caen
Centre d'Investigation Clinique et Technologique 805
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
  More Information

Responsible Party: Nicolas TERZI, MD-PhD, University Hospital, Caen Identifier: NCT01564745     History of Changes
Other Study ID Numbers: Extu-Cough
Study First Received: March 25, 2012
Last Updated: February 3, 2014 processed this record on September 21, 2017