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CompletedNCT01360580DeglutubeUpdated Jan 24, 2013

Swallowing Disorders After Prolonged Mechanical Ventilation

An observational study in Larynx Disease, sponsored by University Hospital, Rouen. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-24.

Sponsored by University Hospital, Rouen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
138
Ages
18 Years and older
Sex
All
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Study 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?)

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Conditions studied

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In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 138 is above the median of 97 across 207 observational studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

More than 7d of invasive mechanical ventilation

Inclusion criteria

  • More than 7 days of invasive mechanical ventilation

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
138 participants (actual)
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What researchers measure

Primary outcomes

  1. Prevalence of swallowing disorders after prolonged invasive ventilation

    Time frame: 48 hours after extubation

Secondary outcomes

  1. Nutritional status at day 28

    Time frame: day 28

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Study locations

2 sites
  • Service de Réanimation Médicale
    Angers, 49933, France
  • service de Réanimation médicale
    Rouen, 76031, France
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References and documents

Publications

  • 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. PubMed 33052476 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01360580
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
May 25, 2011
Start date
Jan 2011
Primary completion
Feb 2012
Completion
Dec 2012
Last update
Jan 24, 2013

Study contacts

Gaetan Beduneau, Doctor
principal investigator · Service de Réanimation médicale Hôpitaux de Rouen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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