Intraoperative Heart Rate Thresholds and Postoperative Mortality

NCT ID: NCT07075744

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 139149 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2025-01-20

Brief Summary

This retrospective observational study investigates the association between intraoperative heart rate and 30-day postoperative mortality among patients undergoing non-cardiac surgery. The findings suggest that heart rate abnormalities during surgery may significantly affect short-term postoperative outcomes.

Detailed Description

This is a retrospective cohort study conducted to evaluate the clinical impact of intraoperative heart rate on postoperative 30-day mortality in patients undergoing non-cardiac surgery. Patient data were extracted from a large institutional electronic medical record database, including demographic variables, comorbidities, anesthesia records, and perioperative outcomes.

Heart rate was continuously recorded at 1-minute or 5-minute intervals during the surgery. Various heart rate parameters-such as minimum, maximum, average, and time-weighted average-were analyzed, and threshold-based metrics (e.g., minutes spent below or above defined thresholds) were computed using a piecewise cubic Hermite interpolating polynomial (PCHIP) method to smooth minute-by-minute fluctuations.

The primary outcome was all-cause mortality within 30 days after surgery. Multivariable logistic regression and sensitivity analyses were performed to adjust for potential confounders. The study aimed to provide clinical insight into the prognostic value of intraoperative heart rate dynamics and to identify modifiable intraoperative risk factors for mortality.

Conditions

HEART RATE

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Non-cardiac Surgery Cohort

This cohort includes adult patients who underwent non-cardiac surgery under general or regional anesthesia. The study retrospectively examined intraoperative heart rate patterns and their association with postoperative 30-day mortality. No intervention was applied as this is an observational study.

Intraoperative Heart Rate Monitoring

Intervention Type: OTHER

This is a non-interventional observational analysis of intraoperative heart rate metrics, including minimum, maximum, average, and time-weighted average heart rate recorded during non-cardiac surgery. The study also includes duration-based metrics such as time spent below or above specific heart rate thresholds. These variables were retrospectively analyzed for their association with 30-day postoperative mortality. No clinical intervention or treatment was administered as part of this study.

Interventions

Intraoperative Heart Rate Monitoring

This is a non-interventional observational analysis of intraoperative heart rate metrics, including minimum, maximum, average, and time-weighted average heart rate recorded during non-cardiac surgery. The study also includes duration-based metrics such as time spent below or above specific heart rate thresholds. These variables were retrospectively analyzed for their association with 30-day postoperative mortality. No clinical intervention or treatment was administered as part of this study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who underwent non-cardiac surgery at our medical center between March 2019 and February 2023
• Age ≥ 18 years
• Availability of complete laboratory data and perioperative vital signs
• Only the first surgery performed after hospital admission was included for patients with multiple

Exclusion Criteria

• Cardiac-related surgical procedures
• Pregnancy at the time of surgery
• Age < 18 years
• Surgeries lasting less than 30 minutes
• Cadaveric procedures
• Missing or incomplete laboratory values or vital sign data

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sung-Hoon Kim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center

Seoul, Songpa-gu, South Korea

Countries

South Korea

Other Identifiers

AMC [2023-0611]

Identifier Type: -

Identifier Source: org_study_id