The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position
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Purpose
The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP)
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebral Ischemia |
Other: Hypocapnic group Other: Normocapnic group |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
- Incidence of cerebral desaturation events [ Time Frame: Intraoperative-first 2 hours ] [ Designated as safety issue: Yes ]Cerebral desaturation events will be measured with near-infrared spectroscopy
- Incidence of nausea and vomiting [ Time Frame: Postanesthesia care unit-first 2 hours ] [ Designated as safety issue: No ]Assessed by recovery nurses
- Postanesthesia care unit length of stay [ Time Frame: Approximately 2 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 86 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Hypocapnic group
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
|
Other: Hypocapnic group
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
Other Name: Hypocapnic group
|
|
Active Comparator: Normocapnic group
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
|
Other: Normocapnic group
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Other Name: Normocapnic group
|
Detailed Description:
Recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The investigators previously observed an association between CDE in the operating room and postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and intraoperative SctO2 on clinical recovery will also be determined.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.
Exclusion Criteria:
- Exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age < 18 years 3) American Society of Anesthesiologists Physical Status IV or V.
Contacts and Locations| Contact: Glenn S Murphy, MD | 857-570-2760 | dgmurphy2@yahoo.com |
| United States, Illinois | |
| NorthShore University HealthSystem | Recruiting |
| Evanston, Illinois, United States, 60201 | |
| Contact: Glenn S Murphy, MD 847-570-2760 dgmurphy2@yahoo.com | |
| Principal Investigator: | Glenn S. Murphy, MD | NorthShore University HealthSystem |
More Information
No publications provided
| Responsible Party: | Glenn S. Murphy, MD, Director, Cardiac Anesthesia and Clinical Research, NorthShore University HealthSystem Research Institute |
| ClinicalTrials.gov Identifier: | NCT01546636 History of Changes |
| Other Study ID Numbers: | EH10-184 |
| Study First Received: | March 2, 2012 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by NorthShore University HealthSystem Research Institute:
|
Cerebral desaturation events Cerebral oximetry Beach chair position |
Additional relevant MeSH terms:
|
Cerebral Infarction Brain Ischemia Ischemia Brain Infarction Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Stroke Vascular Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013