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

Memorial Medical Center

Status

Terminated

Conditions

Traumatic Brain Injury

Respiratory Failure

Treatments

Procedure: Early tracheostomy

Procedure: Late tracheostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT00292097

MMC 05-27

Details and patient eligibility

About

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.

Full 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

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No 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