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

Not Applicable

Terminated

• Conditions: Respiratory Failure; Traumatic Brain Injury
• Interventions: Procedure: Early tracheostomy; Procedure: Late tracheostomy

• Registration Number: NCT00292097
• Lead Sponsor: Memorial Medical Center

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

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-13
• Study First Submitted QC: 2006-02-13
• Study First Posted: 2006-02-15
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-04
• Last Update Posted: 2008-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Early tracheostomy	Early conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury
2	Late tracheostomy	Conventional conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury

Primary Outcome Measures

Name	Time	Method
Total number of mechanical ventilation days	until discharged

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Medical Center; 🇺🇸 Johnstown, Pennsylvania, United States