NCT00729261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
Last Updated

April 28, 2015

Status Verified

August 1, 2008

Enrollment Period

1.7 years

First QC Date

August 1, 2008

Last Update Submit

April 27, 2015

Conditions

Brain Injury

Keywords

mechanical ventilationextubationoutcomesbrain injury

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Score

    6 months

Secondary Outcomes (4)

  • nosocomial pneumonias

    hospital discharge

  • reintubations

    hospital discharge

  • ICU length of stay

    hospital discharge

  • hospital length of stay

    hospital discharge

Study Arms (2)

armA I

EXPERIMENTAL

Patients remain intubated until the patients Glasgow coma score improves to greater than 8.

Procedure: continued intubation

arm 2

EXPERIMENTAL

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

Interventions

extubationPROCEDURE

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.

arm 2
continued intubationPROCEDURE

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

armA I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Coplin WM, Pierson DJ, Cooley KD, Newell DW, Rubenfeld GD. Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med. 2000 May;161(5):1530-6. doi: 10.1164/ajrccm.161.5.9905102.

    PMID: 10806150RESULT

  • Manno EM, Rabinstein AA, Wijdicks EF, Brown AW, Freeman WD, Lee VH, Weigand SD, Keegan MT, Brown DR, Whalen FX, Roy TK, Hubmayr RD. A prospective trial of elective extubation in brain injured patients meeting extubation criteria for ventilatory support: a feasibility study. Crit Care. 2008;12(6):R138. doi: 10.1186/cc7112. Epub 2008 Nov 10.

    PMID: 19000302DERIVED

MeSH Terms

Conditions

Brain Injuries

Interventions

Airway Extubation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsInvestigative Techniques

Study Officials

  • Edward M. Manno, M.D.

    Mayo Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 7, 2008

Study Start

August 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

April 28, 2015

Record last verified: 2008-08

Locations

US(1)