NCT01564745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 22, 2019

Status Verified

February 1, 2014

Enrollment Period

3.8 years

First QC Date

March 25, 2012

Last Update Submit

April 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Interest of systematically cough evaluation before 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 Outcomes (1)

  • Correlation between success of extubation and respiratory parameters

    2 days after extubation

Study Arms (1)

Cough Determinants

OTHER
Other: Functional respiratory evaluation

Interventions

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

Also known as: Pulmonary Function test
Cough Determinants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Hemodynamic instability
  • Absence of consent
  • No cooperation of the patient
  • Hemodynamic instability
  • pH \< 7,30
  • Severe hypoxemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital, Caen

Caen, 1400, France

Location

University Hospital, Garches

Garches, 92380, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Respiratory Physiological Phenomena

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2012

First Posted

March 28, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 22, 2019

Record last verified: 2014-02

Locations