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A Prospective, Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury

NCT ID: NCT00292097

Last Updated: 2008-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of early conversion tracheostomy from endotracheal intubation (ET) to percutaneous, dilatational tracheostomy (PDT) in traumatic brain-injured patients requiring prolonged mechanical ventilation.

Detailed Description

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This is a prospective, randomized trial to evaluate the efficacy of early (less than or equal to 72 hours) versus late (10 to 14 days) conversion from endotracheal intubation to percutaneous, dilatational, translaryngeal tracheostomy for mechanical ventilation of traumatic brain injured patients.

The primary efficacy parameter will be the number of days on mechanical ventilation.

Secondary objectives include:

* Number of days in the hospital
* To assess the incidence of ventilator-acquired pneumonia in each group
* To assess the incidence of accidental extubation in each group
* To assess the incidence of death in each group

Conditions

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Respiratory Failure Traumatic Brain Injury

Keywords

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Respiratory failure Tracheostomy Percutaneous dilatation tracheostomy Endotracheal Conversion Traumatic brain injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Early conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury

Group Type EXPERIMENTAL

Early tracheostomy

Intervention Type PROCEDURE

early conversion - less than or equal to 72 hours

2

Conventional conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury

Group Type ACTIVE_COMPARATOR

Late tracheostomy

Intervention Type PROCEDURE

Late conversion (10-14 days)

Interventions

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Early tracheostomy

early conversion - less than or equal to 72 hours

Intervention Type PROCEDURE

Late tracheostomy

Late conversion (10-14 days)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* TBI defined as penetrating or blunt brain injury including 1)subarachnoid hemorrhage, 2)subdural hemorrhage, 3) epidural hemorrhage, 4)brain contusion, 5)diffuse axonal injury
* mechanically ventilated by endotracheal intubation
* projected to need ventilation support for more than 14 days according to: GCS measured in field less than or equal to 8 and a GCS on day 3 which remains less than or equal to 8
* informed consent obtained from patient or legal representative

Exclusion Criteria

* less than 18 years of age
* projected to need ventilation support for less than 14 days
* anatomical deformity of the neck, including thyromegaly and cervical tumors
* previous tracheostomy
* uncontrolled coagulopathy
* existence of platelet count less than 50,000/mm2
* anti-platelet agents
* clinical evidence of ongoing infection at the proposed tracheostomy site as per physician
* mechanical ventilation with a positive end-expiratory pressure greater than 12 cm H20
* intubated more than 72 hours
* patient has undergone cricothyroidotomy
* cricoid cartilage, trachea, or sternal notch not palpable with neck in position
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Memorial Medical Center

Principal Investigators

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Russell D Dumire, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Medical Center

Stephen L Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Medical Center

Locations

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Memorial Medical Center

Johnstown, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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MMC 05-27

Identifier Type: -

Identifier Source: org_study_id