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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

August 1, 2008
August 1, 2008
August 2004
May 2006   (final data collection date for primary outcome measure)
Modified Rankin Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Prospective Trial of Elective Extubation in Brain Injured Patients.
A Prospective Trial of Elective Extubation in Brain Injured Patients Meeting Extubation Criteria for Ventilatory Support.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Brain Injury
  • 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.
  • Procedure: continued intubation
    patients remain intubated until their Glasgow coma scores improve to greater than 8.
  • Experimental: armA I
    Patients remain intubated until the patients Glasgow coma score improves to greater than 8.
    Intervention: Procedure: continued intubation
  • 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.
    Intervention: Procedure: extubation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 2006
May 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00729261
1210-04
No
Edward M. Manno M.D., Mayo Clinic
Mayo Clinic
Not Provided
Study Director: Edward M. Manno, M.D. Mayo Clinic
Mayo Clinic
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP