A Prospective, Randomized Trial of Early Versus Late Trac... | NCT00292097

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

NCT00292097

Sponsor

Memorial Medical Center

Status

Terminated

Last Update Posted

Jun 5, 2008Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Respiratory Failure
Traumatic Brain Injury

Interventions

Early tracheostomy
Late tracheostomy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty obtaining enrollment

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Feb 13, 2006

First Submission Date that Met QC Criteria

Feb 13, 2006

First Posted Date

Feb 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2008

Last Update Posted Date

Jun 5, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Early conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury	Procedure: Early tracheostomy
2	Active Comparator	Conventional conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury	Procedure: Late tracheostomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early tracheostomy	Procedure	early conversion - less than or equal to 72 hours	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total number of mechanical ventilation days		until discharged

Secondary Outcomes

Measure	Description	Time Frame
Total number of hospital days		until discharged
Incidence of ventilator-associated pneumonia		until discharged
Incidence of accidental extubation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Russell D Dumire, MD	Memorial Medical Center	Principal Investigator
Stephen L Miller, MD	Memorial Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Medical Center		Johnstown	Pennsylvania	15905	United States

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D001930	Brain Injuries
D001927	Brain Diseases

Browse Leaves

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Browse Branches

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