Early Percutaneous Tracheostomy and Swallowing Dysfunction

NCT ID: NCT01268423

Last Updated: 2011-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-06-30

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.

Conditions

Swallowing Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Early percutaneous tracheostomy

Group Type: EXPERIMENTAL

Percutaneous tracheostomy

Intervention Type: PROCEDURE

Percutaneous tracheostomy within the first 4 days of mechanical ventilation.

Prolonged translaryngeal intubation

Group Type: ACTIVE_COMPARATOR

Prolonged translaryngeal intubation

Intervention Type: PROCEDURE

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.

Interventions

Percutaneous tracheostomy

Percutaneous tracheostomy within the first 4 days of mechanical ventilation.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Percutaneous dilatational tracheostomy; Prolonged endotracheal intubation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Comisión Nacional de Investigación Científica y Tecnológica

OTHER_GOV

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Universidad de Chile

Principal Investigators

Carlos M Romero, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Locations

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Carlos M Romero, MD

Role: CONTACT

caromero@redclinicauchile.cl

0562 - 9788264

Mauricio H Ruiz, MD

Role: CONTACT

mruiz@redclinicauchile.cl

0562 - 9788409

Other Identifiers

FONIS SA10I20012

Identifier Type: -

Identifier Source: org_study_id