Cough Determinants in Mechanically Ventilated Patients (Extu-Cough)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01564745
Recruitment Status : Unknown
Verified February 2014 by Nicolas TERZI, University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : March 28, 2012
Last Update Posted : February 4, 2014
INSERM U1075,Caen
Centre d'Investigation Clinique et Technologique 805
Information provided by (Responsible Party):
Nicolas TERZI, University Hospital, Caen

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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Other: Functional respiratory evaluation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cough Determinants in Mechanically Ventilated Patients: a Physiological Study
Study Start Date : March 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Correlation between success of extubation and respiratory parameters [ Time Frame: 2 days after extubation ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nicolas TERZI, MD-PhD, University Hospital, Caen Identifier: NCT01564745     History of Changes
Other Study ID Numbers: Extu-Cough
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014