Early Percutaneous Tracheostomy and Swallowing Dysfunction
|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 ]
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|