Cough Determinants in Mechanically Ventilated Patients (Extu-Cough)

April 18, 2019 updated by: University Hospital, Caen

Cough Determinants in Mechanically Ventilated Patients: a Physiological Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 1400
        • University Hospital, Caen
      • Garches, France, 92380
        • University Hospital, Garches

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Pulmonary Function test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 days after extubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between success of extubation and respiratory parameters
Time Frame: 2 days after extubation
2 days after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

Centre d'Investigation Clinique et Technologique 805
INSERM U1075,Caen

Investigators

  • Principal Investigator: Nicolas TERZI, MD - PhD, University Hospital, Caen
  • Principal Investigator: David Orlikowski, MD-PhD, University Hospital, Garches

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 25, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

February 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • Extu-Cough

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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