A Prospective Trial of Elective Extubation in Brain Injured Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00729261
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : April 28, 2015
Information provided by:
Mayo Clinic

Brief Summary:

Identifying the optimal time of extubation in a brain injured population should improve patient outcome. Brain injured patients usually remain intubated due to concerns of airway maintenance. Current practice argues that unconscious patients need to remain intubated to protect their airways. More recent data however suggests that delaying extubation in this population increases pneumonias and worsens patient outcomes.

We designed a safety and feasibility study of randomizing brain injured patients into early or delayed extubation. The purpose was to gain insight into patient safety concerns and to obtain estimates of sample size needed for a larger study.

Condition or disease Intervention/treatment Phase
Brain Injury Procedure: extubation Procedure: continued intubation Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Trial of Elective Extubation in Brain Injured Patients Meeting Extubation Criteria for Ventilatory Support.
Study Start Date : August 2004
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Arm Intervention/treatment
Experimental: armA I
Patients remain intubated until the patients Glasgow coma score improves to greater than 8.
Procedure: continued intubation
patients remain intubated until their Glasgow coma scores improve to greater than 8.

Experimental: arm 2
Patients that meet standard airway and ventilatory criteria for extubation but have a Glasgow coma score of less than or equal to 8 are immediately extubated.
Procedure: extubation
Brian injured patients that remained intubation solely because of a depressed level of consciousness were randomized into immediate extubation or delayed extubation until their level of consciousness improved.All patients met standard ventilatory, and airway criteria for extubation.

Primary Outcome Measures :
  1. Modified Rankin Score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. nosocomial pneumonias [ Time Frame: hospital discharge ]
  2. reintubations [ Time Frame: hospital discharge ]
  3. ICU length of stay [ Time Frame: hospital discharge ]
  4. hospital length of stay [ Time Frame: hospital discharge ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Resolution or improvement of any pulmonary process requiring mechanical ventilation.
  2. Adequate gas exchange.
  3. Adequate ventilation.
  4. Respiratory rate to tidal volume ratio <105.
  5. Core body temperature < 38 degrees celsius.
  6. Hemoglobin > 8 grams per deciliter.
  7. No sedative medications for 2 hours.

Neurological requirements included:

  1. GCS ≤ 8.
  2. Intracranial pressure (ICP) < 15 cm of water and a cerebral perfusion pressure (CPP) > 60 mm Hg for patients with intracranial pressure monitors.

Exclusion Criteria:

  1. Age < 18 years.
  2. Lack of informed consent by the patients' surrogate.
  3. Dependence on mechanical ventilation for at least two weeks prior to enrollment.
  4. Patients with tracheostomies.
  5. Intubation instituted for therapeutic hyperventilation.
  6. Planned surgical or radiological intervention within the next 72 hours.
  7. Anticipated neurological or medically worsening conditions (i.e develop cerebral edema or vasospasm).
  8. Patients intubated for airway preservation due to airway edema (cervical neck injuries or surgery) as opposed to airway protection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00729261

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Study Director: Edward M. Manno, M.D. Mayo Clinic

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Edward M. Manno M.D., Mayo Clinic Identifier: NCT00729261     History of Changes
Other Study ID Numbers: 1210-04
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: August 2008

Keywords provided by Mayo Clinic:
mechanical ventilation
brain injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries