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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01268423

Enrollment

120

Registered

2010-12-30

Start date

2011-01-31

Completion date

2012-06-30

Last updated

2011-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Swallowing Disorder

Keywords

Percutaneous tracheostomy, Swallowing dysfunction, Mechanical ventilation, Intensive Care

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.

Interventions

PROCEDUREPercutaneous tracheostomy

Percutaneous tracheostomy within the first 4 days of mechanical ventilation.

PROCEDUREProlonged 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of swallowing dysfunction	3 to 5 days after weaning of mechanical ventilation	The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) 3 to 5 days after weaning of mechanical ventilation.

Secondary

Measure	Time frame	Description
Incidence of ventilator-associated pneumonia	28 days	—
Delirium-free and coma-free days	28 days	—
Daily dose of sedatives	28 days	—
Ventilator-free days	28 days	—
Critical Care Unit-free days	90 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.
Hospital length of stay	90 days	—
All cause mortality	90 days	—
ICU-free days	28 days	—

Countries

Chile

Contacts

Primary ContactCarlos M Romero, MD

caromero@redclinicauchile.cl0562 - 9788264

Backup ContactMauricio H Ruiz, MD

mruiz@redclinicauchile.cl0562 - 9788409

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026