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

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.

Study Overview

• Status: Unknown
• Conditions: Swallowing Disorder
• Intervention / Treatment: Procedure: Percutaneous tracheostomy; Procedure: Prolonged translaryngeal intubation

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Carlos M Romero, MD; Phone Number: 0562 - 9788264; Email: caromero@redclinicauchile.cl
• Study Contact Backup: Name: Mauricio H Ruiz, MD; Phone Number: 0562 - 9788409; Email: mruiz@redclinicauchile.cl

Study Locations

• Chile
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile
      • Recruiting
      • Hospital Clínico Universidad de Chile
      • Principal Investigator: Carlos M Romero, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early percutaneous tracheostomy	Procedure: Percutaneous tracheostomy; Percutaneous tracheostomy within the first 4 days of mechanical ventilation.; Other Names: Percutaneous dilatational tracheostomy
Active Comparator: Prolonged translaryngeal intubation	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.; Other Names: Prolonged endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality		90 days
Hospital length of stay		90 days
Ventilator-free days		28 days
ICU-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
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

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: Comisión Nacional de Investigación Científica y Tecnológica
• Investigators: Principal Investigator: Carlos M Romero, MD, University of Chile

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: December 29, 2010
• First Submitted That Met QC Criteria: December 29, 2010
• First Posted (Estimate): December 30, 2010

Study Record Updates

• Last Update Posted (Estimate): January 5, 2011
• Last Update Submitted That Met QC Criteria: January 4, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Intensive Care; Mechanical ventilation; Percutaneous tracheostomy; Swallowing dysfunction
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: FONIS SA10I20012