Assessment of Patient Positioning

Effort to Reduce Postoperative Brachial Neuropraxia Through Nerve Compression

The purpose of this study is to ultimately prevent injuries to nerves during surgical procedures. Living donor liver transplant or hepatectomy (removal of a piece of the liver) patients will receive an arterial line as standard of care. The arterial line helps monitor blood pressure along with the compression of important vessels during surgery. In addition, research participants will undergo neuromuscular monitoring using Somato-Sensory Evoked Potential (SSEP) or Evoked Potential Assessment Device (EPAD). During an operation, neuromuscular monitoring can tell doctors if the nerves being studied are working normally or if they are at risk for injury. This study will help investigators to understand what kind of monitoring is best to prevent nerve injuries during a surgical procedure.

Study Overview

• Status: Completed
• Conditions: Neuropraxia

Detailed Description

As standard of care, research participants undergoing a living donor liver transplant or other liver surgeries will receive a right-sided radial arterial line to monitor his/her blood pressure along with the compression of important vessels during surgery. These measurements will be captured throughout the surgical procedure. If blunting of the arterial line wave form occurs, the anesthesiology team alerts the surgical team to release the retractors until the wave form returns to baseline. Depression of the radial arterial line wave form will be captured, time-stamped, and stored by the research transplant anesthesiology team.

Additionally as part of research, participants will receive neuromuscular monitoring using SSEP or EPAD to measure their nerve signals during the surgery (3-6 hours). SSEP or EPAD measurements will occur at the median and ulnar nerve and will be captured throughout the surgical procedure. The research neuromonitoring team will consists of highly skilled technicians, who monitor patients during neurosurgical and orthopedic surgeries. SSEP or EPAD output captured during the surgery will be time-stamped, stored, and interpreted by a Neurologist. To investigate if a correlation exists, SSEP or EPAD abnormalities will be correlated and analyzed with the arterial wave form depressions.

To determine whether a correlation exists with clinical outcomes, a prospective medical record review will be conducted. Before performing the prospective medical record review, authorized research personnel will obtain informed consent from each participant.

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult living liver donors and liver surgery patients at Northwestern Memorial Hospital (surgical setup is similar for living liver donor surgery and liver surgery (e.g. retractors, arterial line for monitoring, surgeons). Investigators will approach both living liver donors and liver surgery patients for enrollment to receive additional neuromuscular monitoring.

Description

Inclusion Criteria:

• All adult living liver donors and liver surgery patients at Northwestern Memorial Hospital (surgical setup is similar for living liver donor surgery and liver surgery (e.g. retractors, arterial line for monitoring, surgeons). Investigators will approach both living liver donors and liver surgery patients for enrollment to receive additional neuromuscular monitoring.
• All subjects must have given signed, informed consent prior to registration on the study.

Exclusion Criteria:

• Anyone not meeting the inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Living Liver Donor Transplant Donors; All adult living liver donors and liver surgery patients at Northwestern Memorial Hospital (same surgical setup is used for living liver donor surgery and liver surgery (e.g. retractors, arterial line for monitoring, surgeons). Living liver donors and liver surgery patients for enrollment to receive neuromuscular monitoring)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A change in arterial line wave form and a change in the neuromuscular signal using SSEP or EPAD will be measured and tested with the Pearson correlation coefficient as well as nonparametric Spearman's rank correlation coefficient.	To establish the correlation between the wave form of the arterial line readings and neuromuscular monitoring.	12 mos

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Daniela P Ladner, MD, MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 21, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: nerve compression
• Other Study ID Numbers: STU00105002