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

This study has been terminated.
(Difficulty obtaining enrollment)
Sponsor:
Information provided by:
Memorial Medical Center
ClinicalTrials.gov Identifier:
NCT00292097
First received: February 13, 2006
Last updated: June 4, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention
Respiratory Failure
Traumatic Brain Injury
Procedure: Early tracheostomy
Procedure: Late tracheostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memorial Medical Center:

Primary Outcome Measures:
  • Total number of mechanical ventilation days [ Time Frame: until discharged ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total number of hospital days [ Time Frame: until discharged ] [ Designated as safety issue: No ]
  • Incidence of ventilator-associated pneumonia [ Time Frame: until discharged ] [ Designated as safety issue: Yes ]
  • Incidence of accidental extubation [ Time Frame: until discharged ] [ Designated as safety issue: Yes ]
  • Incidence of death [ Time Frame: until discharged ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: February 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292097

Locations
United States, Pennsylvania
Memorial Medical Center
Johnstown, Pennsylvania, United States, 15905
Sponsors and Collaborators
Memorial Medical Center
Investigators
Principal Investigator: Russell D Dumire, MD Memorial Medical Center
Principal Investigator: Stephen L Miller, MD Memorial Medical Center
  More Information

No publications provided

Responsible Party: Russel Dumire, MD, FACS/MMC Progeam Director, General Surgery Residency Program, Memorial Medical Center
ClinicalTrials.gov Identifier: NCT00292097     History of Changes
Other Study ID Numbers: MMC 05-27
Study First Received: February 13, 2006
Last Updated: June 4, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Medical Center:
Respiratory failure
Tracheostomy
Percutaneous dilatation tracheostomy
Endotracheal Conversion
Traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Respiratory Insufficiency
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014