A Prospective Trial of Elective Extubation in Brain Injured Patients.

Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729261
• Other study ID #: 1210-04
• Status: Completed
• Phase: Phase 1
• First received: August 1, 2008
• Last updated: April 27, 2015
• Start date: August 2004
• Est. completion date: May 2006

Study information

• Verified date: August 2008
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Score		6 months	No
Secondary	nosocomial pneumonias		hospital discharge	Yes
Secondary	reintubations		hospital discharge	Yes
Secondary	ICU length of stay		hospital discharge	No
Secondary	hospital length of stay		hospital discharge	No

External Links

•   Mayo Clinic Clinical Trials