Cerebral Oximetry in Single Lung Ventilation Thoracic Surgery

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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 hypothesis is that subjects randomized to open cerebral oximetry monitoring that have active intervention to mitigate observed desaturations will have measurable postoperative clinical outcome benefits when compared to the patients randomized to blinded cerebral oximetry monitoring with no active interventions to mitigate desaturations.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Anesthetics; Dopamine; Ephedrine; Phenylephrine; Propofol; Sevoflurane; Vasoconstrictor Agents

Criteria

Inclusion Criteria:

1. 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)

2. Able to adequately complete a baseline mini-mental status examination (MMSE)

3. Able to complete a baseline confusion assessment method (CAM) examination

4. Able to obtain bi-frontal baseline rSO2 values prior to induction of anesthesia

Exclusion Criteria:

1. Any patient who has participated in a clinical study of an investigational drug or device in the past 30 days

2. Any patient who the principal investigator feels at any time or for any reason should not participate in this clinical study

3. Withdrawal of informed consent for any reason