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

NCT00292097 | Terminated

• 1 other identifier: MMC 05-27
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Failure; Traumatic Brain Injury

Keywords

Respiratory failure; Tracheostomy; Percutaneous dilatation tracheostomy; Endotracheal Conversion; Traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Total number of mechanical ventilation days

  until discharged

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Procedure: Early tracheostomy

2

ACTIVE COMPARATOR

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

Procedure: Late tracheostomy

Interventions

Early tracheostomy PROCEDURE

early conversion - less than or equal to 72 hours

1

Late tracheostomy PROCEDURE

Late conversion (10-14 days)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Medical Center: lead

Study Sites (1)

Memorial Medical Center

Johnstown, Pennsylvania, 15905, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Russell D Dumire, MD

  Memorial Medical Center

  PRINCIPAL INVESTIGATOR

• Stephen L Miller, MD

  Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 15, 2006
• Study Start: February 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 5, 2008

Record last verified: 2008-06

Locations

US (1)