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A Prospective Trial of Elective Extubation in Brain Injured Patients.

This study has been completed.
Information provided by:
Mayo Clinic Identifier:
First received: August 1, 2008
Last updated: April 27, 2015
Last verified: August 2008

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 Intervention Phase
Brain Injury
Procedure: extubation
Procedure: continued intubation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Trial of Elective Extubation in Brain Injured Patients Meeting Extubation Criteria for Ventilatory Support.

Further study details as provided by Mayo Clinic:

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

Secondary Outcome Measures:
  • nosocomial pneumonias [ Time Frame: hospital discharge ]
  • reintubations [ Time Frame: hospital discharge ]
  • ICU length of stay [ Time Frame: hospital discharge ]
  • hospital length of stay [ Time Frame: hospital discharge ]

Enrollment: 16
Study Start Date: August 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Additional Information:
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
Study First Received: August 1, 2008
Last Updated: April 27, 2015

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 processed this record on March 28, 2017