A Prospective Trial of Elective Extubation in Brain Injured Patients. - Full Text View

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 I

MedlinePlus related topics:

Head and Brain Injuries Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study

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 ] [ 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
armA I: Experimental 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.
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 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:

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.

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

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

Publications of Results:

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.

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