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A Prospective Trial of Elective Extubation in Brain Injured Patients.

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00729261
First received: August 1, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Modified Rankin Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • nosocomial pneumonias [ Time Frame: hospital discharge ] [ Designated as safety issue: Yes ]
  • reintubations [ Time Frame: hospital discharge ] [ Designated as safety issue: Yes ]
  • ICU length of stay [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
  • hospital length of stay [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729261

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

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Edward M. Manno M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00729261     History of Changes
Other Study ID Numbers: 1210-04
Study First Received: August 1, 2008
Last Updated: August 1, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
mechanical ventilation
extubation
outcomes
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

ClinicalTrials.gov processed this record on May 16, 2013