Early Percutaneous Tracheostomy and Swallowing Dysfunction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Chile.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by:
University of Chile
ClinicalTrials.gov Identifier:
NCT01268423
First received: December 29, 2010
Last updated: January 4, 2011
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Swallowing Disorder
Procedure: Percutaneous tracheostomy
Procedure: Prolonged translaryngeal intubation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Early Percutaneous Tracheostomy on the Incidence of Swallowing Dysfunction in Critically Ill Patients on Mechanical Ventilation. A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Chile:

Primary Outcome Measures:
  • Incidence of swallowing dysfunction [ Time Frame: 3 to 5 days after weaning of mechanical ventilation ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Incidence of ventilator-associated pneumonia [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Delirium-free and coma-free days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Daily dose of sedatives [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • ICU-free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Critical Care Unit-free days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early percutaneous tracheostomy Procedure: Percutaneous tracheostomy
Percutaneous tracheostomy within the first 4 days of mechanical ventilation.
Other Name: Percutaneous dilatational tracheostomy
Active Comparator: Prolonged translaryngeal intubation 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.
Other Name: Prolonged endotracheal intubation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268423

Contacts
Contact: Carlos M Romero, MD 0562 - 9788264 caromero@redclinicauchile.cl
Contact: Mauricio H Ruiz, MD 0562 - 9788409 mruiz@redclinicauchile.cl

Locations
Chile
Hospital Clínico Universidad de Chile Recruiting
Santiago, Región Metropolitana, Chile
Principal Investigator: Carlos M Romero, MD         
Sponsors and Collaborators
University of Chile
Comisión Nacional de Investigación Científica y Tecnológica
Investigators
Principal Investigator: Carlos M Romero, MD University of Chile
  More Information

No publications provided

Responsible Party: Carlos Romero. Principal Investigator, Universidad de Chile
ClinicalTrials.gov Identifier: NCT01268423     History of Changes
Other Study ID Numbers: FONIS SA10I20012
Study First Received: December 29, 2010
Last Updated: January 4, 2011
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by University of Chile:
Percutaneous tracheostomy
Swallowing dysfunction
Mechanical ventilation
Intensive Care

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 26, 2014