Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass

NCT07508579 | Recruiting

• 1 other identifier: SEAH-DOAonCPB-2026
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate whether hypothermia affects the relationship between electroencephalography-derived indices during cardiac surgery in adult patients undergoing cardiopulmonary bypass. The main questions it aims to answer are: Does the correlation between Bispectral Index (BIS) and Patient State Index (PSI) change between normothermic and hypothermic phases during cardiopulmonary bypass? How do BIS and PSI values change in response to decreasing body temperature? Participants will: Undergo standard general anesthesia for elective on-pump coronary artery bypass surgery Be monitored simultaneously with BIS and PSI devices during surgery Have data recorded at predefined temperature-based time points during cardiopulmonary bypass

Conditions

Cardiopulmonary Bypass; Hypothermia; Anesthesia; Depth of Anesthesia Monitoring

Keywords

Bispectral Index; Patient State Index; Processed EEG; Cardiac Surgery; Hypothermic CPB; Depth of Anesthesia; Intraoperative Monitoring

Outcome Measures

Primary Outcomes (1)

• Difference in Correlation Between Bispectral Index (BIS) and Patient State Index (PSI) Under Normothermic and Hypothermic Conditions

  The primary outcome is the difference in Pearson correlation coefficients between BIS and PSI measured at predefined normothermic (36°C) and hypothermic (32°C) phases during cardiopulmonary bypass. Correlation coefficients will be calculated separately for each phase and compared using Fisher z-transformation to determine whether hypothermia alters the relationship between these indices.

  Intraoperative (during cardiopulmonary bypass at predefined time points)

Secondary Outcomes (3)

• Change in Bispectral Index (BIS) and Patient State Index (PSI) per Degree Celsius During Cooling and Rewarming

  Intraoperative (during cooling and rewarming phases of cardiopulmonary bypass)

• Effect of CPB Initiation on the Relationship Between Bispectral Index (BIS) and Patient State Index (PSI)

  Intraoperative (comparison of pre-CPB and post-CPB initiation time points)

• Agreement in Clinical Depth Categories Between Bispectral Index (BIS) and Patient State Index (PSI)

  Intraoperative (during predefined normothermic and hypothermic phases of cardiopulmonary bypass)

Study Arms (1)

Elective On-Pump CABG Patients Undergoing CPB

Adult patients undergoing elective on-pump coronary artery bypass grafting with cardiopulmonary bypass will be included. All participants will receive standard general anesthesia and intraoperative management according to institutional protocols. Bispectral Index (BIS) and Patient State Index (PSI) will be monitored simultaneously throughout surgery. Data will be collected at predefined time points across normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass to evaluate the relationship between these indices under varying temperature conditions.

Other: Simultaneous BIS and PSI Monitoring

Interventions

Simultaneous BIS and PSI Monitoring OTHER

This observational study does not involve any experimental intervention. All participants will receive standard anesthesia and surgical care according to institutional protocols. The study focuses on simultaneous intraoperative monitoring using Bispectral Index (BIS) and Patient State Index (PSI) devices. Sensors for both monitors will be applied prior to induction of anesthesia, and values will be recorded at predefined time points during normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass. No changes will be made to routine clinical management, and all treatments will be determined by the attending anesthesiologist.

Elective On-Pump CABG Patients Undergoing CPB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective on-pump coronary artery bypass grafting (CABG) with cardiopulmonary bypass at a single tertiary care center will be included. All participants will receive standard general anesthesia and perioperative management according to institutional protocols. Patients will be monitored intraoperatively with both Bispectral Index (BIS) and Patient State Index (PSI) devices, and data will be collected at predefined time points during normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass.

You may qualify if:

• Age ≥18 years
• Elective on-pump Coronary Artery Bypass Grafting (CABG) surgery
• Planned use of general anesthesia
• Written informed consent

You may not qualify if:

• Preexisting neurological disease
• Use of medications affecting Electroencephalography (e.g., antiepileptics)
• Severe hepatic dysfunction
• Emergency surgery
• Inadequate signal quality for anesthesia depth monitoring

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation

Sakarya, Serdivan, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Meybohm P, Gruenewald M, Hocker J, Renner J, Graesner JT, Ilies C, Scholz J, Bein B. Correlation and agreement between the bispectral index vs. state entropy during hypothermic cardio-pulmonary bypass. Acta Anaesthesiol Scand. 2010 Feb;54(2):169-75. doi: 10.1111/j.1399-6576.2009.02138.x. Epub 2009 Oct 15.

  PMID: 19839944 BACKGROUND

• Belletti A, Lee DK, Yanase F, Naorungroj T, Eastwood GM, Bellomo R, Weinberg L. Changes in SedLine-derived processed electroencephalographic parameters during hypothermia in patients undergoing cardiac surgery with cardiopulmonary bypass. Front Cardiovasc Med. 2023 Jul 4;10:1084426. doi: 10.3389/fcvm.2023.1084426. eCollection 2023.

  PMID: 37469479 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• AYÇA TAŞ TUNA, Professor, M.D.

  Sakarya University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMET R DOĞAN, M.D

CONTACT

+905427988070; a.ridvandogan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

TU (1)