NCT00780078

Brief Summary

Patients with failed extubation stay significantly longer in an intensive care unit (ICU) and have a higher mortality rate, than those intubated successfully. Reintubation is associated with life-threatening complications and a poor prognosis. Functional respiratory tests are frequently used as weaning parameters, however, they are not accurate enough to predict extubation failure. The incidence of swallowing dysfunction is underestimated, mainly among patients whose intubation lasts longer than 48 h.We previously observed that the assessment of the swallowing function and oropharyngeal motricity, conducted by the physiotherapist before extubation could be helpful for making decisions to extubate patients intubated for over 6 days. The objective of this study is to validate a scale previously devised and used for physiotherapist bedside evaluation of the swallowing function and oropharyngeal motricity, among patients intubated for over 6 days, to determine whether this scale is a good predictor of airway secretion-related extubation failure.Expected results : to validate a scale previously devised called " physiotherapist evaluation of the swallowing function and oropharyngeal motricity before extubation" by the mean of a multicentric study. In our hypothesis the clinical parameters studied could be predictive of extubation failure. Then, this evaluation could help the medical decision in the choice of the good time for extubation. The final objective is to lower the mortality related to extubation failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

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

October 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

January 4, 2017

Status Verified

December 1, 2016

Enrollment Period

1.9 years

First QC Date

October 24, 2008

Last Update Submit

January 3, 2017

Conditions

Central Nervous System DiseasesAcute Respiratory FailureShockHeart FailureAcute Poisoning

Keywords

Intensive care unitExtubation failurePhysiotherapistPre-extubation bedside testsSwallowing disorders

Outcome Measures

Primary Outcomes (1)

  • Rate of reintubation within the 72 hours after extubation

    72 hours after extubation

Secondary Outcomes (4)

  • Delay for reintubation (hours)

    72 hours after extubation

  • Number of daily pharyngeal or tracheal suctioning

    72 hours after extubation

  • Pulmonary infection

    72 hours after extubation

  • Mortality

    7 days

Study Arms (1)

1

Patients intubated orotracheally for over 6 days

Procedure: extubation

Interventions

extubationPROCEDURE

extubation failure in patients intubated orotracheally

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the objective of this study is to validate a scale previously devised and used for physiotherapist bedside evaluation of the swallowing function and oropharyngal motricity, among patients intubated for over 6 days, to determine whether this scale is a good predictor of airway secretion-related extubation failure

You may qualify if:

  • age over 18 years
  • patients intubated orotracheally for over 6 days
  • patients fulfilling usual medical criteria for extubation, after a successful test of spontaneous ventilation, according to the French consensus conference (2001).

You may not qualify if:

  • post ENT surgery- previous swallowing disorders
  • chronic vegetative status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital LARIBOISIERE

Paris, 75010, France

Location

Related Publications (1)

  • Houze MH, Deye N, Mateo J, Megarbane B, Bizouard F, Baud FJ, Payen de la Garanderie D, Vicaut E, Yelnik AP; EVAKIN Study Group. Predictors of Extubation Failure Related to Aspiration and/or Excessive Upper Airway Secretions. Respir Care. 2020 Apr;65(4):475-481. doi: 10.4187/respcare.07025. Epub 2019 Nov 19.

    PMID: 31744867DERIVED

MeSH Terms

Conditions

Central Nervous System DiseasesShockHeart FailureDeglutition Disorders

Interventions

Airway Extubation

Condition Hierarchy (Ancestors)

Nervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsInvestigative Techniques

Study Officials

  • Alain YELNIK, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 27, 2008

Study Start

October 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

January 4, 2017

Record last verified: 2016-12

Locations

FR(1)