Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292097
Status:
TERMINATED
Last Update Posted:
2008-06-05
First Post:
2006-02-13
Brief Title:
A Prospective Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury
Sponsor:
Memorial Medical Center
Organization:
Memorial Medical Center
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty obtaining enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None