NCT01360580

Brief Summary

Epidemiology study for evaluation of incidence of swallowing disorders (SD) after prolonged invasive ventilation (more than seven days), using a clinical statement. All consecutive patients are screened, and clinical evaluation is performed during 48h after patient's extubation. If a SD exist, a new evaluation is realized 48h after. Three groups will be created (1.no SD, 2.transitory SD and 3.persistent SD (eg persistent after 48h)). Data complementary are notified at day 28 (pneumonia? nutritional status?)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

1.1 years

First QC Date

May 24, 2011

Last Update Submit

January 23, 2013

Conditions

Larynx Disease

Outcome Measures

Primary Outcomes (1)

  • Prevalence of swallowing disorders after prolonged invasive ventilation

    48 hours after extubation

Secondary Outcomes (1)

  • Nutritional status at day 28

    day 28

Eligibility Criteria

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

More than 7d of invasive mechanical ventilation

You may qualify if:

  • More than 7 days of invasive mechanical ventilation

You may not qualify if:

  • Age \< 18 years old
  • Preexistent swallowing disorders, stroke, tracheostomy
  • Failure of patient's agreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de Réanimation Médicale

Angers, 49933, France

Location

service de Réanimation médicale

Rouen, 76031, France

Location

Related Publications (1)

  • Beduneau G, Souday V, Richard JC, Hamel JF, Carpentier D, Chretien JM, Bouchetemble P, Laccoureye L, Astier A, Tanguy V, Mercat A, Beloncle F, Tamion F. Persistent swallowing disorders after extubation in mechanically ventilated patients in ICU: a two-center prospective study. Ann Intensive Care. 2020 Oct 14;10(1):138. doi: 10.1186/s13613-020-00752-x.

    PMID: 33052476DERIVED

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Gaetan Beduneau, Doctor

    Service de Réanimation médicale Hôpitaux de Rouen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 25, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2012

Study Completion

December 1, 2012

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

FR(2)