Clinical trial NCT00292097: A Prospective, Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Failure
Traumatic Brain Injury
Keywords: Respiratory failure
Tracheostomy
Percutaneous dilatation tracheostomy
Endotracheal Conversion
Traumatic brain injury
Lead sponsor: Memorial Medical Center
Sponsor class: OTHER
First posted: 2006-02-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Total number of mechanical ventilation days
timeFrame: until discharged
Secondary outcomes:
measure: Total number of hospital days
timeFrame: until discharged
measure: Incidence of ventilator-associated pneumonia
timeFrame: until discharged
measure: Incidence of accidental extubation
timeFrame: until discharged
measure: Incidence of death
timeFrame: until discharged
Other outcomes:
Locations:
city: Johnstown
country: United States
facility: Memorial Medical Center
state: Pennsylvania
Study officials:
affiliation: Memorial Medical Center
name: Russell D Dumire, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Medical Center
name: Stephen L Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: