Early Percutaneous Tracheostomy and Swallowing Dysfunction

Phase 3

• Conditions: Swallowing Disorder
• Interventions: Procedure: Percutaneous tracheostomy; Procedure: Prolonged translaryngeal intubation

• Registration Number: NCT01268423
• Lead Sponsor: University of Chile

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.

Detailed Description

The development of initial resuscitation maneuvers, associated with a better knowledge of the physiopathology of critical illnesses and the technological development experienced by critical care medicine, allow us to give vital support to patients for long periods of time. In this scenario, a considerable proportion of critically ill patients may require translaryngeal intubation and invasive mechanical ventilation. Patients who require prolonged translaryngeal intubation have a high risk of developing swallowing dysfunction, a condition predisposing to secretions aspiration. Until now, there has been no demonstration of a causal association between the duration of translaryngeal intubation and development of swallowing dysfunction. However, all the studies about this topic have been performed on patients submitted to prolonged translaryngeal intubation. Clinical studies have documented the development of early laryngotracheal lesions after intubation, which might explain post extubation dysfunction of swallowing reflex, probably as consequence of alteration of mechanic and chemo-receptors of the pharyngeal and laryngeal mucosa. There are no studies evaluating the impact of an early percutaneous tracheostomy on the incidence of swallowing dysfunction in critical care patients. The investigators have documented a 38% of swallowing dysfunction in our critically ill patients submitted to prolonged mechanical ventilation. The hypothesis of the study is that performance of an early percutaneous tracheostomy, within the first 4 days of translaryngeal intubation, in critical care patients on mechanical ventilation, reduces the incidence of swallowing dysfunction. The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) by a trained otolaryngologist, 3 to 5 days after weaning of mechanical ventilation.

Study Timeline

• Status Verified: 2010-12
• Study First Submitted: 2010-12-29
• Study First Submitted QC: 2010-12-29
• Study First Posted: 2010-12-30
• Study Start: 2011-01
• Last Update Submitted: 2011-01-04
• Last Update Posted: 2011-01-05
• Primary Completion: 2012-04
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early percutaneous tracheostomy	Percutaneous tracheostomy	-
Prolonged translaryngeal intubation	Prolonged translaryngeal intubation	-

Primary Outcome Measures

Name	Time	Method
Incidence of swallowing dysfunction	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.

Secondary Outcome Measures

Name	Time	Method
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
Critical Care Unit-free days	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	90 days
All cause mortality	90 days

Trial Locations

Locations (1)

Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, Región Metropolitana, Chile