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

A Prospective, Randomized Trial of Early Versus Conventional Conversion From Endotracheal Intubation to Percutaneous Tracheostomy for Ventilatory Support of Trauma Patients With Severe Brain Injury

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Failure; Traumatic Brain Injury
• Intervention / Treatment: Procedure: Early tracheostomy; Procedure: Late tracheostomy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Johnstown, Pennsylvania, United States, 15905
      • Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Early conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury	Procedure: Early tracheostomy; early conversion - less than or equal to 72 hours
ACTIVE_COMPARATOR: 2; Conventional conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury	Procedure: Late tracheostomy; Late conversion (10-14 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total number of mechanical ventilation days	until discharged

Secondary Outcome Measures

Outcome Measure	Time Frame
Total number of hospital days	until discharged
Incidence of ventilator-associated pneumonia	until discharged
Incidence of accidental extubation	until discharged
Incidence of death	until discharged

Collaborators and Investigators

• Sponsor: Memorial Medical Center
• Investigators: Principal Investigator: Russell D Dumire, MD, Memorial Medical Center; Principal Investigator: Stephen L Miller, MD, Memorial Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (ACTUAL): May 1, 2008
• Study Completion (ACTUAL): May 1, 2008

Study Registration Dates

• First Submitted: February 13, 2006
• First Submitted That Met QC Criteria: February 13, 2006
• First Posted (ESTIMATE): February 15, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): June 5, 2008
• Last Update Submitted That Met QC Criteria: June 4, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Traumatic brain injury; Tracheostomy; Respiratory failure; Percutaneous dilatation tracheostomy; Endotracheal Conversion
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Respiratory Insufficiency; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: MMC 05-27