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A Prospective Trial of Elective Extubation in Brain Injured Patients.

Primary Purpose

Brain Injury

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

extubation

continued intubation

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring mechanical ventilation, extubation, outcomes, brain injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

armA I

arm 2

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Modified Rankin Score

Secondary Outcome Measures

nosocomial pneumonias

reintubations

ICU length of stay

hospital length of stay

Full Information

NCT ID

NCT00729261

First Posted

August 1, 2008

Last Updated

April 27, 2015

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00729261

Brief Title

A Prospective Trial of Elective Extubation in Brain Injured Patients.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injury

Keywords

mechanical ventilation, extubation, outcomes, brain injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

armA I

Arm Type

Experimental

Arm Description

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

Arm Title

arm 2

Arm Type

Experimental

Arm Description

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 Type

Procedure

Intervention Name(s)

extubation

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

continued intubation

Intervention Description

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

Primary Outcome Measure Information:

Title

Modified Rankin Score

Time Frame

6 months

Secondary Outcome Measure Information:

Title

nosocomial pneumonias

Time Frame

hospital discharge

Title

reintubations

Time Frame

hospital discharge

Title

ICU length of stay

Time Frame

hospital discharge

Title

hospital length of stay

Time Frame

hospital discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward M. Manno, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Study Director

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10806150

Citation

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.

Results Reference

result

PubMed Identifier

19000302

Citation

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.

Results Reference

derived

Links:

URL

http://clinicaltrials.mayo.edu

Description

Mayo Clinic Clinical Trials

Learn more about this trial

A Prospective Trial of Elective Extubation in Brain Injured Patients.

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