Early Percutaneous Tracheostomy and Swallowing Dysfunction

University of Chile

Status and phase: Unknown; Phase 3

Conditions: Swallowing Disorder

Treatments: Procedure: Prolonged translaryngeal intubation; Procedure: Percutaneous tracheostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01268423

FONIS SA10I20012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Early percutaneous tracheostomy

Experimental group

Treatment:

Procedure: Percutaneous tracheostomy

Prolonged translaryngeal intubation

Active Comparator group

Treatment:

Procedure: Prolonged translaryngeal intubation