Actively Recruiting
Feasibility Study of the Nociception Level (NOL) Index for Intraoperative Assessment of Nociception During Cardiac Surgery
Led by University Hospital, Strasbourg, France · Updated on 2025-08-06
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Cardiac surgery often causes acute or chronic pain due to the body's response to harmful stimuli during surgery under general anesthesia. This trial evaluates the use of a multiparametric device, the PMD200 ae, which measures the Nociception Level Index (NOL) to monitor pain signals during cardiac surgery. The study aims to improve pain management by adjusting analgesic doses based on real-time nociception monitoring, particularly during coronary artery bypass grafting procedures. Participants will undergo on-pump cardiac surgery while the NOL monitor is used to assess nociception continuously. A finger probe connected to the PMD200 ae device measures a single NOL index number ranging from 0 to 100 that reflects the level of nociception. This device integrates heart rate, pulse variability, skin conductance, and temperature to provide a comprehensive pain-related signal during surgery. Throughout the surgery, researchers will track the time the NOL monitor signal is lost in relation to the total surgery duration. This primary outcome assesses the feasibility of using the monitor during cardiac procedures. Participants will be evaluated at the time of surgery with no long-term follow-up detailed. The study focuses on monitoring effectiveness and device signal stability during the operative period.
CONDITIONS
Brief Title
Nociception Monitoring During Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients
- Patients undergoing on-pump cardiac surgery
- Specific cardiac procedure: coronary artery bypass grafting
You will not qualify if you...
- Patients with preoperative cardiac arrhythmia
- Patients with a cardiac pacemaker
- Emergency cardiac surgical procedure
- Peripheral artery disease stage 2
- Patients in shock prior to cardiac surgery (mean arterial pressure 65mmHg with vasopressors)
- Persons participating in another interventional research
- Patient refusal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (surgery day)
Participants undergo cardiac surgery during which the nociception monitor device is used intraoperatively to assess nociception.
1 surgical procedure visit
Trial Site Locations
Total: 1 location
1
Service d'Anesthésie Réanimation Cardiovasculaire
Strasbourg, France, 67000
Actively Recruiting
Research Team
W
Walid OULEHRI, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here