Early Percutaneous Tracheostomy and Swallowing Dysfunction

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Swallowing Disorder

Intervention / Treatment
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* Procedure: Percutaneous tracheostomy
* Procedure: Prolonged translaryngeal intubation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early percutaneous tracheostomy<br> | Procedure: Percutaneous tracheostomy<br>* Percutaneous tracheostomy within the first 4 days of mechanical ventilation.<br>* Other names: Percutaneous dilatational tracheostomy;|
| Active Comparator: Prolonged translaryngeal intubation<br> | Procedure: Prolonged translaryngeal intubation<br>* 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.<br>* Other names: Prolonged endotracheal intubation;|

What is the study measuring?
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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 |
| --- | --- | --- |
| Ventilator-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 | 
| ICU-free days |  | 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 | 
| Hospital length of stay |  | 90 days | 
| All cause mortality |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous tracheostomy, Swallowing dysfunction, Mechanical ventilation, Intensive Care