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Early Percutaneous Tracheostomy and Swallowing Dysfunction

NCT01268423 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-01-05

No results posted yet for this study

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.

Conditions

  • Swallowing Disorder

Interventions

PROCEDURE

Percutaneous tracheostomy

Percutaneous tracheostomy within the first 4 days of mechanical ventilation.

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.

Sponsors & Collaborators

  • Comisión Nacional de Investigación Científica y Tecnológica

    collaborator OTHER_GOV

  • University of Chile

    lead OTHER

Principal Investigators

  • Carlos M Romero, MD · University of Chile

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-04-30
Completion
2012-06-30

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01268423 on ClinicalTrials.gov