Early Percutaneous Tracheostomy and Swallowing Dysfunction
Impact of Early Percutaneous Tracheostomy on the Incidence of Swallowing Dysfunction in Critically Ill Patients on Mechanical Ventilation. A Randomized Clinical Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
The aim of the study is to determine if performing an early tracheostomy (within the first 4 days of endotracheal intubation) in critically ill patients on mechanical ventilation, reduces the incidence of swallowing dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2010
CompletedFirst Posted
Study publicly available on registry
December 30, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJanuary 5, 2011
December 1, 2010
1.2 years
December 29, 2010
January 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of swallowing dysfunction
The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) 3 to 5 days after weaning of mechanical ventilation.
3 to 5 days after weaning of mechanical ventilation
Secondary Outcomes (8)
Ventilator-free days
28 days
Incidence of ventilator-associated pneumonia
28 days
Delirium-free and coma-free days
28 days
Daily dose of sedatives
28 days
ICU-free days
28 days
- +3 more secondary outcomes
Study Arms (2)
Early percutaneous tracheostomy
EXPERIMENTALProlonged translaryngeal intubation
ACTIVE COMPARATORInterventions
Percutaneous tracheostomy within the first 4 days of mechanical ventilation.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan, Chile
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos M Romero, MD
University of Chile
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 29, 2010
First Posted
December 30, 2010
Study Start
January 1, 2011
Primary Completion
April 1, 2012
Study Completion
June 1, 2012
Last Updated
January 5, 2011
Record last verified: 2010-12