Cardiac SurgerySYDNOSNCT04712773
Comparison of the Nociception Monitoring Devices During Cardiac Surgery.
A study testing PMD-200 monitor and Surgical Pleth Index monitor in people with Cardiac Surgery, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- PMD-200 monitor and Surgical Pleth Index monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 22 Feb 2021to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiac Surgery
- Being tested
- PMD-200 monitor, Surgical Pleth Index monitor
- Keywords
- cardiac surgery, pain, nociception
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMD-200 monitorDevice
Patient is connected to non-invasive PMD-200 monitor, measuring Nociception Level
Surgical Pleth Index monitorDevice
Patient is connected to non-invasive monitor measuring Surgical Pleth Index
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery patients | Other | Patients scheduled for elective cardiac surgery (CABG or valve surgery). Receives: Device: PMD-200 monitor; Device: Surgical Pleth Index monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPI values measured at several timepoints during cardiac surgery
SPI (Surgical Pleth Index) - index measuring nociceptive response based on pulse and pulse amplitude.
Measured: 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
Measured: Values are measured during the course of the cardiac surgery procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start22 Feb 2021
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tadeusz Musialowicz, PhD, MD, Study director, Kuopio University Hospital, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712773
- Sponsor's protocol ID
- Kuopio University Hospital
- Acronym
- SYDNOS
- Status last verified
- Mar 2025
- First submitted
- 21 Dec 2020
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Nociception Monitoring Devices During Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT04712773
- Acronym / sponsor ID
- SYDNOS / Kuopio University Hospital
- Conditions
- Cardiac Surgery
- Keywords
- cardiac surgery, pain, nociception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery patients | Other | Device: PMD-200 monitor, Device: Surgical Pleth Index monitorPatients scheduled for elective cardiac surgery (CABG or valve surgery). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMD-200 monitorPatient is connected to non-invasive PMD-200 monitor, measuring Nociception Level | Device | Cardiac surgery patients |
| Surgical Pleth Index monitorPatient is connected to non-invasive monitor measuring Surgical Pleth Index | Device | Cardiac surgery patients |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadeusz Musialowicz, PhD, MD study director
Kuopio University Hospital, Department of Anesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMD-200 monitor and Surgical Pleth Index monitor in people with Cardiac Surgery, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPI values measured at several timepoints during cardiac surgery (time frame: Values are measured during the course of the cardiac surgery procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.