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Early Percutaneous Tracheostomy and Swallowing Dysfunction

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ClinicalTrials.gov Identifier: NCT01268423
Recruitment Status : Unknown
Verified December 2010 by University of Chile.
Recruitment status was:  Recruiting
First Posted : December 30, 2010
Last Update Posted : January 5, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Swallowing Disorder Procedure: Percutaneous tracheostomy Procedure: Prolonged translaryngeal intubation Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : June 2012
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Incidence of swallowing dysfunction [ Time Frame: 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 Outcome Measures :
  1. Ventilator-free days [ Time Frame: 28 days ]
  2. Incidence of ventilator-associated pneumonia [ Time Frame: 28 days ]
  3. Delirium-free and coma-free days [ Time Frame: 28 days ]
  4. Daily dose of sedatives [ Time Frame: 28 days ]
  5. ICU-free days [ Time Frame: 28 days ]
  6. Critical Care Unit-free days [ Time Frame: 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.

  7. Hospital length of stay [ Time Frame: 90 days ]
  8. All cause mortality [ Time Frame: 90 days ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268423

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

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
Principal Investigator: Carlos M Romero, MD University of Chile
More Information

Responsible Party: Carlos Romero. Principal Investigator, Universidad de Chile
ClinicalTrials.gov Identifier: NCT01268423     History of Changes
Other Study ID Numbers: FONIS SA10I20012
First Posted: December 30, 2010    Key Record Dates
Last Update Posted: January 5, 2011
Last Verified: December 2010

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