Swallowing Disorders After Prolonged Mechanical Ventilation

Larynx Disease Clinical Trial

— Deglutube  

Official title:

Current Care Study of Incidence and Consequences of Swallowing Disorders After Invasive Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360580
• Other study ID #: 2009/110/HP
• Secondary ID: 2008-A00057-50
• Status: Completed
• Phase: N/A
• First received: May 24, 2011
• Last updated: January 23, 2013
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Observational

Clinical Trial 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?)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• More than 7 days of invasive mechanical ventilation

Exclusion Criteria:

• Age < 18 years old

• Preexistent swallowing disorders, stroke, tracheostomy

• Failure of patient's agreement

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deglutition Disorders
• Laryngeal Diseases
• Larynx Disease

Locations

Country	Name	City	State
France	Service de Réanimation Médicale	Angers
France	service de Réanimation médicale	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of swallowing disorders after prolonged invasive ventilation		48 hours after extubation	Yes
Secondary	Nutritional status at day 28		day 28	Yes