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Completed

NCT Number: NCT01225185

Assessing Cerebral Blood Flow Autoregulation During Surgery in the Head-up Position

Neurological injury after elective shoulder surgery in the beach chair position is thought to result from cerebral hypoperfusion and should therefore be preventable by appropriate hemodynamic monitoring and management. This proposal will use a system to continuously monitor cerebral blood flow autoregulation to identify safe arterial blood pressure targets in patients in the beach chair position, compared with a control cohort having orthopedic surgery in the lateral decubitus supine position. Autoregulation data will be compared against a new, highly specific and sensitive serum biomarker of neurologic injury, glial fibrillary acid protein, and postoperative neurocognitive testing results.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years old or older undergoing shoulder arthroscopy in the beach chair position or lateral decubitus position without elevation of the head.

Exclusion criteria

  • Women of child bearing potential require a negative urine HCG test to be enrolled. Patients unable to attend postoperative cognitive testing sessions will be excluded from the study as will those with known allergy to adhesive tape.

Treatment and study plan

Primary outcomes

  1. cerebral oximetry index between subjects in the head up or supine position during surgery under general anesthesia

    Time frame: During surgery

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Anesthesia Patient Safety Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Oct 20, 2010
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.