Optic Nerve Sheath After Extracorporeal Circulation

January 5, 2023 updated by: University Medical Centre Maribor

The Influence of Extracorporeal Circulation During Cardiac Surgery on Optic Nerve Sheath Diameter

The purpose of this study is to assess the influence of extracorporeal circulation during cardiac surgery on the optic nerve sheath diameter (ONSD) after the surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

ONSD will be measured before and 1 hour after the surgery and in the morning of day 1 after the surgery. Fluid balance and lactate will be measured too. PONV will be assessed. Patients will be evaluated with MoCA test on the day before surgery and on the day 3 after the surgery for cognitive disfunction.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andreja Möller Petrun, PhD
  • Phone Number: 38623211571
  • Email: drejapet@web.de

Study Locations

  • Slovenia
      • Maribor, Slovenia, 2000
        • Recruiting
        • University Medical Centre Maribor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years or older which are scheduled for heart surgery (coronary bypass, valve disease, thoracic aortic disease) in which cardiopulmonary bypass is used.

Description

Inclusion Criteria:

  • heart surgery with use of cardiopulmonary bypass

Exclusion Criteria:

  • pregnancy and lactation
  • neurologic disorders
  • hyperthyroidism
  • optic nerve disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
standard cardiopulmonary bypass
patients 18 year or older undergoing heart surgery with standard cardiopulmonary bypass
Diagnostic test: ultrasound measurement of the optic nerve sheath diameter
ultrasound measurement of the optic nerve sheath diameter
Diagnostic test: MoCA test
MoCA test is a short bedside test for measuring cognitive disfunction
mini-cardiopulmonary bypass
patients 18 year or older undergoing heart surgery with standard mini-cardiopulmonary bypass
Diagnostic test: ultrasound measurement of the optic nerve sheath diameter
ultrasound measurement of the optic nerve sheath diameter
Diagnostic test: MoCA test
MoCA test is a short bedside test for measuring cognitive disfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound measuring of optic nerve sheath diameter baseline
Time Frame: Before start of surgery
Baseline optic nerve sheath diameter measurement before start of surgery with a linear ultrasound probe (Scan) in coronal and axial plane
Before start of surgery
Ultrasound measuring of optic nerve sheath diameter end of surgery
Time Frame: 1 hour after the end of surgery
Optic nerve sheath diameter measurement 1 hour after the end of surgery with a linear ultrasound probe in coronal and axial plane
1 hour after the end of surgery
Ultrasound measuring of optic nerve sheath diameter day 1
Time Frame: day 1 after the surgery
Optic nerve sheath diameter measurement in the morning on day 1 after the surgery with a linear ultrasound probe in coronal and axial plane
day 1 after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative cognitive disfunction measured with the MoCA test
Time Frame: on the day before surgery, on day 3 after the surgery
MoCA test is a validated test for cognitive disfunction, especially in patients who are elderly than 60 years, the study is comparing the MoCA test values on the day before surgery with the values on day 3 after the surgery
on the day before surgery, on day 3 after the surgery
postoperative nausea and vomiting (PONV)
Time Frame: during the first 24 hours after surgery
Postoperative nausea and vomiting is common after cardiac surgery, the occurrence of postoperative nausea and vomiting will be recorded
during the first 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Maribor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 29, 2021

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKC-MB-KME-59/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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