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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00292097
• Other study ID #: MMC 05-27
• Status: Terminated
• Phase: N/A
• First received: February 13, 2006
• Last updated: June 4, 2008
• Start date: February 2006
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: Memorial Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Respiratory Failure
• Respiratory Insufficiency
• Traumatic Brain Injury

Intervention

Procedure:
• Early tracheostomy
early conversion - less than or equal to 72 hours
• Late tracheostomy
Late conversion (10-14 days)

Locations

Country	Name	City	State
United States	Memorial Medical Center	Johnstown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of mechanical ventilation days		until discharged	No
Secondary	Total number of hospital days		until discharged	No
Secondary	Incidence of ventilator-associated pneumonia		until discharged	Yes
Secondary	Incidence of accidental extubation		until discharged	Yes
Secondary	Incidence of death		until discharged	Yes