Early Percutaneous Tracheostomy and Swallowing Dysfunction

Swallowing Disorder Clinical Trial

Official title:

Impact of Early Percutaneous Tracheostomy on the Incidence of Swallowing Dysfunction in Critically Ill Patients on Mechanical Ventilation. A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01268423
• Other study ID #: FONIS SA10I20012
• Status: Recruiting
• Phase: Phase 3
• First received: December 29, 2010
• Last updated: January 4, 2011
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2010
• Source: University of Chile
• Contact: Carlos M Romero, MD
• Phone: 0562 - 9788264
• Email: caromero[@]redclinicauchile.cl
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deglutition Disorders
• Swallowing Disorder

Intervention

Procedure:
• Percutaneous tracheostomy
Percutaneous tracheostomy within the first 4 days of mechanical ventilation.
• 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.

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago	Región Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Comisión Nacional de Investigación Científica y Tecnológica

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Ventilator-free days		28 days	No
Secondary	Incidence of ventilator-associated pneumonia		28 days	Yes
Secondary	Delirium-free and coma-free days		28 days	Yes
Secondary	Daily dose of sedatives		28 days	Yes
Secondary	ICU-free days		28 days	No
Secondary	Critical Care Unit-free 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.	90 days	No
Secondary	Hospital length of stay		90 days	No
Secondary	All cause mortality		90 days	Yes