Early Percutaneous Tracheostomy and Swallowing Dysfunction
Recruitment status was Recruiting
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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 |
- 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.
- 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 |
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| Contact: Carlos M Romero, MD | 0562 - 9788264 | caromero@redclinicauchile.cl |
| Contact: Mauricio H Ruiz, MD | 0562 - 9788409 | mruiz@redclinicauchile.cl |
| Chile | |
| Hospital Clínico Universidad de Chile | Recruiting |
| Santiago, Región Metropolitana, Chile | |
| Principal Investigator: Carlos M Romero, MD | |
| 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 June 17, 2013