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

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:

MedlinePlus related topics: Injuries Respiratory Failure Traumatic Brain Injury Wounds

U.S. FDA Resources

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

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 June 18, 2013