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Cough Determinants in Mechanically Ventilated Patients (Extu-Cough)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital, Caen
Sponsor:
Collaborators:
INSERM U1075,Caen
Centre d'Investigation Clinique et Technologique 805
Information provided by (Responsible Party):
Nicolas TERZI, University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01564745
First received: March 25, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University Hospital, Caen:

Primary Outcome Measures:
  • Interest of systematically cough evaluation before extubation [ Time Frame: 2 days after extubation ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564745

Contacts
Contact: Nicolas TERZI, MD - PhD +33231065268 terzi-n@chu-caen.fr

Locations
France
University Hospital, Caen Recruiting
Caen, France, 1400
Contact: Nicolas TERZI, MD - PhD    +33231065268    terzi-n@chu-caen.fr   
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       f.lofaso@rpc.aphp.fr   
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
Investigators
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

No publications provided

Responsible Party: Nicolas TERZI, MD-PhD, University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01564745     History of Changes
Other Study ID Numbers: Extu-Cough
Study First Received: March 25, 2012
Last Updated: February 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on November 27, 2014