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Completed

NCT Number: NCT00729261

A Prospective Trial of Elective Extubation in Brain Injured Patients.

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.

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Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Neurological requirements included:

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

Exclusion criteria

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

Treatment and study plan

extubation

Procedure

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.

continued intubation

Procedure

patients remain intubated until their Glasgow coma scores improve to greater than 8.

Primary outcomes

  1. Modified Rankin Score

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Prospective Trial of Elective Extubation in Brain Injured Patients Meeting Extubation Criteria for Ventilatory Support.

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 7, 2008
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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