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

Sponsor

Memorial Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00292097

Collaborator

(none)

Enrollment

Location

Arms

26.9

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure Traumatic Brain Injury	Procedure: Early tracheostomy Procedure: Late tracheostomy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Total number of mechanical ventilation days [until discharged]

Secondary Outcome Measures

Total number of hospital days [until discharged]
Incidence of ventilator-associated pneumonia [until discharged]
Incidence of accidental extubation [until discharged]
Incidence of death [until discharged]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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