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

NCT01225185 | Completed

• 2 other identifiers: APSF1R01HL092259
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shouldersurgery

Keywords

neurological complications; brain blood flow autoregulation

Outcome Measures

Primary Outcomes (1)

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

  During surgery

Secondary Outcomes (2)

• 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.

  During surgery

• To assess the association between impaired cerebral blood flow autoregulation and postoperative neurocognitive decline and elevation of serum glial fibrillary acid protein.

  1 month after surgery for neurocognitive decline; perioperatively for serum GFAP levels.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

120 patients undergoing shoulder surgery in the supine lateral position and 120 subjects undergoing surgery in the beach chair position.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Anesthesia Patient Safety Foundation: collaborator

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Study Officials

• Charles W Hogue, MD

  The Johns Hopkins Medical Institutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 20, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2015
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (1)