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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01268423 |
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Date of registration:
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29/12/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Early Percutaneous Tracheostomy and Swallowing Dysfunction
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Scientific title:
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Impact of Early Percutaneous Tracheostomy on the Incidence of Swallowing Dysfunction in Critically Ill Patients on Mechanical Ventilation. A Randomized Clinical Trial |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01268423 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Chile
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Contacts
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Name:
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Carlos M Romero, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Chile |
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Name:
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Carlos M Romero, MD |
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Address:
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Telephone:
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0562 - 9788264 |
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Email:
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caromero@redclinicauchile.cl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent has been obtained for the procedure
- Patients whose need of mechanical ventilation is estimated in = 7 days and require
a percutaneous tracheostomy
Exclusion Criteria:
- Patients younger than 18 years old
- Patients with neurologic pathology
- Patients with dysphagia history
- Patients whose MV duration is estimated in < 7 days
- Patients with airway obstruction requiring an emergency tracheostomy
- Patients already having a tracheostomy in situ
- Pregnancy
- Patients who have already been enrolled on another trial
- Patients with absolute contraindication to perform a percutaneous tracheostomy
- Patients with high risk of dying, life expectancy of < 48 hours
- Patients in whom limitation of therapy has been decided
- Family rejection to participate in the study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Swallowing Disorder
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Intervention(s)
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Procedure: Prolonged translaryngeal intubation
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Procedure: Percutaneous tracheostomy
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Primary Outcome(s)
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Incidence of swallowing dysfunction
[Time Frame: 3 to 5 days after weaning of mechanical ventilation]
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Secondary Outcome(s)
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Daily dose of sedatives
[Time Frame: 28 days]
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Ventilator-free days
[Time Frame: 28 days]
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All cause mortality
[Time Frame: 90 days]
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ICU-free days
[Time Frame: 28 days]
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Critical Care Unit-free days
[Time Frame: 90 days]
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Delirium-free and coma-free days
[Time Frame: 28 days]
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Hospital length of stay
[Time Frame: 90 days]
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Incidence of ventilator-associated pneumonia
[Time Frame: 28 days]
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Secondary ID(s)
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FONIS SA10I20012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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