Assessing Cerebral Blood Flow Autoregulation During Surgery in the Head-up Position
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|ClinicalTrials.gov Identifier: NCT01225185|
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : August 22, 2017
|Condition or disease|
Neurologic injury under general anesthesia in the beach chair position is believed to result from cerebral hypoperfusion.1 We hypothesize that brain hypoperfusion in this circumstance is caused by blood pressure monitoring that does not reflect of cerebral perfusion pressure. Maintenance of arterial blood pressure above an individual's lower limit of cerebral blood flow autoregulation would prevent this devastating complication. Near infrared spectroscopy can be used to continuously monitor autoregulation with the cerebral oximetry index (COx), a moving linear correlation coefficient between cortical tissue oxygen saturation and arterial pressure. We hypothesize that subjects in the beach chair position have impaired cerebral blood flow autoregulation compared with subjects undergoing surgery in the lateral decubitus supine position. We will test this hypothesis by comparing CBF autoregulation data, including the percentage of time patients undergoing elective surgery have abnormal autoregulation, in the beach chair position versus supine position. We will establish the range of arterial pressure required to maintain autoregulation in the two groups. Cerebral autoregulation results will be assessed for a relationship with postoperative neurocognitive dysfunction and with serum glial fibrillary acid protein levels, a biomarker of brain injury.
The specific aims of this study are:
- To compare the average cerebral oximetry index and the percentage of time with abnormal COx between subjects in the head up or supine position during surgery under general anesthesia.
- To compare the range of arterial blood pressure required for a normal cerebral oximetry index between subjects anesthetized in the head up or supine position.
- To assess the association between impaired cerebral blood flow autoregulation and postoperative neurocognitive decline 1 month after surgery and perioperative elevation of serum glial fibrillary acid protein.
Monitoring autoregulation non-invasively with COx has the potential to improve patient safety by delineating individualized limits of safe ABP for patients at risk of neurologic injury.
|Study Type :||Observational|
|Actual Enrollment :||240 participants|
|Official Title:||Assessing Cerebral Blood Flow Autoregulation in the Head-up Versus Supine Position During General Anesthesia and Its Relationship With Postoperative Neurocognitive Changes and Serum Biomarkers of Brain Injury|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||April 2015|
Patients undergoing shoulder surgery
This observational study will compare cerebral blood flow autoregulation in patients undergoing surgery in either the supine lateral position or the semi-recumbent or "beach chair" position. The choice of patient positioning is not randomized but based on usual surgical considerations.
- cerebral oximetry index between subjects in the head up or supine position during surgery under general anesthesia [ Time Frame: During surgery ]
- To compare the range of arterial blood pressure required for a normal cerebral oximetry index between subjects anesthetized in the head up or supine position. [ Time Frame: During surgery ]
- To assess the association between impaired cerebral blood flow autoregulation and postoperative neurocognitive decline and elevation of serum glial fibrillary acid protein. [ Time Frame: 1 month after surgery for neurocognitive decline; perioperatively for serum GFAP levels. ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225185
|United States, Maryland|
|The Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Charles W Hogue, MD||The Johns Hopkins Medical Institutions|