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

Primary Purpose

Respiratory Failure, Traumatic Brain Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early tracheostomy
Late tracheostomy
Sponsored by
Memorial Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Respiratory failure, Tracheostomy, Percutaneous dilatation tracheostomy, Endotracheal Conversion, Traumatic brain injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total number of mechanical ventilation days

Secondary Outcome Measures

Total number of hospital days
Incidence of ventilator-associated pneumonia
Incidence of accidental extubation
Incidence of death

Full Information

First Posted
February 13, 2006
Last Updated
June 4, 2008
Sponsor
Memorial Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00292097
Brief Title
A Prospective, Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Terminated
Why Stopped
Difficulty obtaining enrollment
Study Start Date
February 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Traumatic Brain Injury
Keywords
Respiratory failure, Tracheostomy, Percutaneous dilatation tracheostomy, Endotracheal Conversion, Traumatic brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Early conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury
Arm Title
2
Arm Type
Active Comparator
Arm Description
Conventional conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury
Intervention Type
Procedure
Intervention Name(s)
Early tracheostomy
Intervention Description
early conversion - less than or equal to 72 hours
Intervention Type
Procedure
Intervention Name(s)
Late tracheostomy
Intervention Description
Late conversion (10-14 days)
Primary Outcome Measure Information:
Title
Total number of mechanical ventilation days
Time Frame
until discharged
Secondary Outcome Measure Information:
Title
Total number of hospital days
Time Frame
until discharged
Title
Incidence of ventilator-associated pneumonia
Time Frame
until discharged
Title
Incidence of accidental extubation
Time Frame
until discharged
Title
Incidence of death
Time Frame
until discharged

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell D Dumire, MD
Organizational Affiliation
Memorial Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen L Miller, MD
Organizational Affiliation
Memorial Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Medical Center
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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