Early Percutaneous Tracheostomy and Swallowing Dysfunction
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|ClinicalTrials.gov Identifier: NCT01268423|
Recruitment Status : Unknown
Verified December 2010 by University of Chile.
Recruitment status was: Recruiting
First Posted : December 30, 2010
Last Update Posted : January 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Swallowing Disorder||Procedure: Percutaneous tracheostomy Procedure: Prolonged translaryngeal intubation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Impact of Early Percutaneous Tracheostomy on the Incidence of Swallowing Dysfunction in Critically Ill Patients on Mechanical Ventilation. A Randomized Clinical Trial|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||June 2012|
|Experimental: Early percutaneous tracheostomy||
Procedure: Percutaneous tracheostomy
Percutaneous tracheostomy within the first 4 days of mechanical ventilation.
Other Name: Percutaneous dilatational tracheostomy
|Active Comparator: Prolonged translaryngeal intubation||
Procedure: Prolonged translaryngeal intubation
Prolonged endotracheal intubation, and reevaluation at day 10 to establish the requirement of percutaneous tracheostomy. If clinical condition determines that the patient needs a percutaneous tracheostomy, this will be performed between days 11 and 14.
Other Name: Prolonged endotracheal intubation
- Incidence of swallowing dysfunction [ Time Frame: 3 to 5 days after weaning of mechanical ventilation ]The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) 3 to 5 days after weaning of mechanical ventilation.
- Ventilator-free days [ Time Frame: 28 days ]
- Incidence of ventilator-associated pneumonia [ Time Frame: 28 days ]
- Delirium-free and coma-free days [ Time Frame: 28 days ]
- Daily dose of sedatives [ Time Frame: 28 days ]
- ICU-free days [ Time Frame: 28 days ]
- Critical Care Unit-free days [ Time Frame: 90 days ]Length of stay at Critical Care Unit involve days of stay in thre Intensive Care Unit, plus the days of stay in the Intermediate Care Unit.
- Hospital length of stay [ Time Frame: 90 days ]
- All cause mortality [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268423
|Contact: Carlos M Romero, MD||0562 - email@example.com|
|Contact: Mauricio H Ruiz, MD||0562 - firstname.lastname@example.org|
|Hospital Clínico Universidad de Chile||Recruiting|
|Santiago, Región Metropolitana, Chile|
|Principal Investigator: Carlos M Romero, MD|
|Principal Investigator:||Carlos M Romero, MD||University of Chile|