Comparison of the Nociception Monitoring Devices During Cardiac Surgery. (SYDNOS)

October 25, 2023 updated by: Kuopio University Hospital
The purpose of this study is to compare the values of Surgical Pleth Index (SPI) and Nociception Level Index (NOL) measured simultaneously during cardiac surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants are given oral and written information about the course of the trial, associated risks and benefits and about the handling of the personal data on the day before the surgery by one of the investigators. Participants are also given written information about patient's rights and insurance, the aim of the trial and its course. 40 adult cardiac surgery patients will be recruited for the study. NOL and SPI values will be measured during the cardiac surgery procedure. All patients receive oral premedication and standardized anesthesia.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

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

Study Locations

  • Finland
    • Northern Savo
      • Kuopio, Northern Savo, Finland, 70029
        • Recruiting
        • Kuopio University Hospital
        • 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • coronary artery disease of heart valve disorder qualified for the surgical treatment
  • participant understands the course of the trial and its aim
  • participant has given informed written consent

Exclusion Criteria:

  • participant has not given consent
  • neurological or psychical disorders (psychiatric medication)
  • dementia
  • alcohol or substance abuse
  • central nervous system medication (medication for epilepsy or neuropathic pain)

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cardiac surgery patients
Patients scheduled for elective cardiac surgery (CABG or valve surgery).
Device: PMD-200 monitor
Patient is connected to non-invasive PMD-200 monitor, measuring Nociception Level
Device: Surgical Pleth Index monitor
Patient is connected to non-invasive monitor measuring Surgical Pleth Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPI values measured at several timepoints during cardiac surgery
Time Frame: Values are measured during the course of the cardiac surgery procedure
SPI (Surgical Pleth Index) - index measuring nociceptive response based on pulse and pulse amplitude.
Values are measured during the course of the cardiac surgery procedure
NOL values measured at several timepoints during cardiac surgery
Time Frame: Values are measured during the course of the cardiac surgery procedure
NOL (Nociception Level Index) - nociception index based on heart rate and its changes, pulse wave amplitude, skin impedance and its changes, temperature and their variations
Values are measured during the course of the cardiac surgery procedure

Collaborators and Investigators

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

Sponsor

Kuopio University Hospital

Investigators

  • Study Director: Tadeusz Musialowicz, PhD, MD, Kuopio University Hospital, Department of Anesthesiology and Intensive Care

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)

February 22, 2021

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Kuopio University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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