Clinical trial NCT01268423: Early Percutaneous Tracheostomy and Swallowing Dysfunction
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Swallowing Disorder
Keywords: Percutaneous tracheostomy
Swallowing dysfunction
Mechanical ventilation
Intensive Care
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
First posted: 2010-12-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of swallowing dysfunction
timeFrame: 3 to 5 days after weaning of mechanical ventilation
Secondary outcomes:
measure: Ventilator-free days
timeFrame: 28 days
measure: Incidence of ventilator-associated pneumonia
timeFrame: 28 days
measure: Delirium-free and coma-free days
timeFrame: 28 days
measure: Daily dose of sedatives
timeFrame: 28 days
measure: ICU-free days
timeFrame: 28 days
measure: Critical Care Unit-free days
timeFrame: 90 days
measure: Hospital length of stay
timeFrame: 90 days
measure: All cause mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: Región Metropolitana
Study officials:
affiliation: University of Chile
name: Carlos M Romero, MD
role: PRINCIPAL_INVESTIGATOR
References: