A Prospective, Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury
June 4, 2008 updated by: Memorial Medical Center
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Johnstown, Pennsylvania, United States, 15905
- Memorial Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
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
|
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
|
Late conversion (10-14 days)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total number of mechanical ventilation days
Time Frame: until discharged
|
until discharged
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total number of hospital days
Time Frame: until discharged
|
until discharged
|
|
Incidence of ventilator-associated pneumonia
Time Frame: until discharged
|
until discharged
|
|
Incidence of accidental extubation
Time Frame: until discharged
|
until discharged
|
|
Incidence of death
Time Frame: until discharged
|
until discharged
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Russell D Dumire, MD, Memorial Medical Center
- Principal Investigator: Stephen L Miller, MD, Memorial Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMC 05-27
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.