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Early Percutaneous Tracheostomy and Swallowing Dysfunction

Primary Purpose

Swallowing Disorder

Status
Unknown status
Phase
Phase 3
Locations
Chile
Study Type
Interventional
Intervention
Percutaneous tracheostomy
Prolonged translaryngeal intubation
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Swallowing Disorder focused on measuring Percutaneous tracheostomy, Swallowing dysfunction, Mechanical ventilation, Intensive Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Clínico Universidad de ChileRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early percutaneous tracheostomy

Prolonged translaryngeal intubation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Ventilator-free days
Incidence of ventilator-associated pneumonia
Delirium-free and coma-free days
Daily dose of sedatives
ICU-free 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.
Hospital length of stay
All cause mortality

Full Information

First Posted
December 29, 2010
Last Updated
January 4, 2011
Sponsor
University of Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica
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1. Study Identification

Unique Protocol Identification Number
NCT01268423
Brief Title
Early Percutaneous Tracheostomy and Swallowing Dysfunction
Official Title
Impact of Early Percutaneous Tracheostomy on the Incidence of Swallowing Dysfunction in Critically Ill Patients on Mechanical Ventilation. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Disorder
Keywords
Percutaneous tracheostomy, Swallowing dysfunction, Mechanical ventilation, Intensive Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early percutaneous tracheostomy
Arm Type
Experimental
Arm Title
Prolonged translaryngeal intubation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Percutaneous tracheostomy
Other Intervention Name(s)
Percutaneous dilatational tracheostomy
Intervention Description
Percutaneous tracheostomy within the first 4 days of mechanical ventilation.
Intervention Type
Procedure
Intervention Name(s)
Prolonged translaryngeal intubation
Other Intervention Name(s)
Prolonged endotracheal intubation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of swallowing dysfunction
Description
The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) 3 to 5 days after weaning of mechanical ventilation.
Time Frame
3 to 5 days after weaning of mechanical ventilation
Secondary Outcome Measure Information:
Title
Ventilator-free days
Time Frame
28 days
Title
Incidence of ventilator-associated pneumonia
Time Frame
28 days
Title
Delirium-free and coma-free days
Time Frame
28 days
Title
Daily dose of sedatives
Time Frame
28 days
Title
ICU-free days
Time Frame
28 days
Title
Critical Care Unit-free days
Description
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.
Time Frame
90 days
Title
Hospital length of stay
Time Frame
90 days
Title
All cause mortality
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos M Romero, MD
Phone
0562 - 9788264
Email
caromero@redclinicauchile.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Mauricio H Ruiz, MD
Phone
0562 - 9788409
Email
mruiz@redclinicauchile.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos M Romero, MD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
State/Province
Región Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos M Romero, MD

12. IPD Sharing Statement

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Early Percutaneous Tracheostomy and Swallowing Dysfunction

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