- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07061548
- Original Trial
Algorithm Predicting Intraoperative Changes in Cardiac Output Using Capnography
Development of an Artificial Intelligence Model for Predicting Intraoperative Changes in Cardiac Output Using Capnography During General Anesthesia
Study Overview
Status
Intervention / Treatment
Detailed Description
Anesthesiologists strive to maintain adequate cardiac output during surgery. However, conventional monitoring of cardiac output requires an invasive procedure (risk) and an additional device (cost).
Because most surgeries are performed without any invasive monitors, anesthesiologists must manage the patients without cardiac output information.
However, modern anesthesia machines usually provide capnography, and continuous capnography monitoring can help estimate changes in cardiac output. Therefore, investigators aim to develop an artificial intelligence algorithm to predict intraoperative changes in cardiac output using capnography in patients undergoing surgery under general anesthesia.
Investigators train a model using capnography data (5-minute duration) related to a 20% or greater decrease in cardiac output during the same period. The developed model can provide an alarm for a decrease in cardiac output based on the change in capnography.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Heejoon Jeong, MD
- Phone Number: +82-2-3410-0841
- Email: heejoonjeong@skku.edu
Study Locations
-
-
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Seoul, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center
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Contact:
- Heejoon Jeong, MD
- Phone Number: +82-2-3410-0841
- Email: heejoonjeong@skku.edu
-
Principal Investigator:
- Heejoon Jeong, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Elective surgery under general anesthesia
- Adult patients (18 < age < 76)
- Patients who were monitored invasive arterial blood pressure (waveform) and capnography (numeric)
Exclusion Criteria:
- Emergency surgery
- Cardiovascular and thoracic surgery
- Known Asthma and Chronic obstructive pulmonary disease (COPD)
- Preoperative pulmonary function test (PFT) abnormality over moderate grade
- Intraoperative monitoring duration less than 30 minutes
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
capnography-cardiac output cohort
Adult patients who underwent surgery under general anesthesia with capnography and invasive arterial blood pressure monitor
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictability of algorithm
Time Frame: Every time points with interval of 5 minutes during surgery
|
The performance of the algorithm to predict whether cardiac output has decreased by more than 20% compared to 5 minutes ago.
Predictability is estimated by area under the receiver-operating characteristic curve analysis.
|
Every time points with interval of 5 minutes during surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SMC2025-06-120-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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