NCT04712773

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

December 21, 2020

Last Update Submit

March 4, 2025

Conditions

Cardiac Surgery

Keywords

cardiac surgerypainnociception

Outcome Measures

Primary Outcomes (2)

  • SPI values measured at several timepoints during cardiac surgery

    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

    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

Study Arms (1)

Cardiac surgery patients

OTHER

Patients scheduled for elective cardiac surgery (CABG or valve surgery).

Device: PMD-200 monitorDevice: Surgical Pleth Index monitor

Interventions

PMD-200 monitorDEVICE

Patient is connected to non-invasive PMD-200 monitor, measuring Nociception Level

Cardiac surgery patients
Surgical Pleth Index monitorDEVICE

Patient is connected to non-invasive monitor measuring Surgical Pleth Index

Cardiac surgery patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tadeusz Musialowicz, PhD, MD

    Kuopio University Hospital, Department of Anesthesiology and Intensive Care

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2020

First Posted

January 15, 2021

Study Start

February 22, 2021

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)