Status:
TERMINATED
Cerebral Oximetry in Single Lung Ventilation Thoracic Surgery
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Hypoxia
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
This is a prospective, randomized controlled pilot study of cerebral oximetry use in elderly patients undergoing thoracic surgical procedures that require the use of single lung ventilation. The hypot...
Detailed Description
Study Rationale The use of bi-frontal, near infrared spectrophotometry (NIRS) based cerebral oximetry monitoring has been demonstrated to result in improved clinical outcomes in both general surgery p...
Eligibility Criteria
Inclusion
- Any male or female patient ≥ 65 years of age and able to provide informed consent (or consent may be provided by a legally authorized representative) who is scheduled for a thoracic surgical procedure that is expected to involve the use of intraoperative single lung ventilation (SLV)
- Able to adequately complete a baseline mini-mental status examination (MMSE)
- Able to complete a baseline confusion assessment method (CAM) examination
- Able to obtain bi-frontal baseline rSO2 values prior to induction of anesthesia
Exclusion
- Any patient who has participated in a clinical study of an investigational drug or device in the past 30 days
- Any patient who the principal investigator feels at any time or for any reason should not participate in this clinical study
- Withdrawal of informed consent for any reason
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2016
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01866657
Start Date
June 1 2013
End Date
November 10 2016
Last Update
July 5 2022
Active Locations (1)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44126