Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position

NCT02674334 | Completed Results

• 1 other identifier: 1409418786
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on participants undergoing shoulder surgery in the beach chair position (BCP) to determine cerebral desaturation events (CDE) and to further determine cognitive changes pre and post surgery using the Mini Mental State Exam.

Conditions

Injury as a Result of Positioning

Keywords

orthopedic procedures

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With 20+% Cerebral Desaturation Events

  Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position

  one day

Secondary Outcomes (1)

• Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value

  baseline and up to two weeks

Study Arms (2)

NIRS Monitored Not Treated

ACTIVE COMPARATOR

Anesthesiologist blinded to Near Infrared Spectroscopy (NIRS)

Device: NIRS monitored not treated

NIRS Monitored and Treated

ACTIVE COMPARATOR

Anesthesiologist treats based on Near Infrared Spectroscopy (NIRS)

Device: NIRS

Interventions

NIRS DEVICE

Near infrared spectroscopy (NIRS) monitor allows anesthesiologist to treat cerebral desaturations according to NIRS results while maintaining Mean Arterial Pressure (MAP) at least 60mmHG or at least 80% of baseline

Also known as: Near infrared spectroscopy

NIRS Monitored and Treated

NIRS monitored not treated DEVICE

Near infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care.

Also known as: Near infrared spectroscopy

NIRS Monitored Not Treated

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years of age
• elective shoulder surgery in the beach chair position

You may not qualify if:

• less than 18 years of age
• preoperative score of 23 or less on the pre-operative Mini Mental State Exam
• traumatic brain injury
• transient ischemic attack
• cerebrovascular incident
• any apparent clinical neurologic dysfunction
• carotid artery stenosis
• known vascular malformation in head
• inability to have blood pressure measured in the opposite extremity
• malignant hyperthermia

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506-9196, United States

Location

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

It is difficult to generalize the results of the study, few CDEs, to similar populations. Intubation may be related to the occurrence of CDEs or may have been related to patient co-morbidities and not the actual intubation.

Results Point of Contact

• Title: Dr. George K Bal
• Organization: West Virginia University Department of Orthopaedics

gbal@hsc.wvu.edu

304-293-1310

Study Officials

• George K Bal, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: February 4, 2016
• Study Start: October 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 11, 2017
• Results First Posted: September 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)