Cough Determinants in Mechanically Ventilated Patients

NCT ID: NCT01564745

Last Updated: 2019-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mechanical Ventilation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cough Determinants

Group Type OTHER

Functional respiratory evaluation

Intervention Type OTHER

Each enrolled patients has a pulmonary function test before and after extubation, and repeatedly at D1, D3, D5 (if they are always hospitalized)

Interventions

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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)

Intervention Type OTHER

Other Intervention Names

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Pulmonary Function test

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas TERZI, MD - PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Frédéric Lofaso, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Garches

David Orlikowski, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Garches

Locations

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University Hospital, Caen

Caen, , France

Site Status

University Hospital, Garches

Garches, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 29404723 (View on PubMed)

Other Identifiers

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Extu-Cough

Identifier Type: -

Identifier Source: org_study_id

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