NCT01360580CompletedNot Applicable
Current Care Study of Incidence and Consequences of Swallowing Disorders After Invasive Mechanical Ventilation
University Hospital, Rouen2 sites in 1 country138 target enrollmentStarted: January 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 138
- Locations
- 2
- Primary Endpoint
- Prevalence of swallowing disorders after prolonged invasive ventilation
Study Overview
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?)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Prevalence of swallowing disorders after prolonged invasive ventilation
Time Frame: 48 hours after extubation
Secondary Outcomes
- Nutritional status at day 28(day 28)
Investigators
Study Sites (2)
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