NCT07061548

Brief Summary

Conventional monitoring of cardiac output requires an invasive procedure and an additional device, which can lead to increased risk and cost. Investigators developed an artificial intelligence algorithm to predict intraoperative changes in cardiac output using capnography in patients undergoing surgery under general anesthesia.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,005

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

July 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 2, 2025

Last Update Submit

July 15, 2025

Conditions

Keywords

artificial intelligencegeneral anesthesiacapnographycardiac output

Outcome Measures

Primary Outcomes (1)

  • Predictability of algorithm

    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

Study Arms (1)

capnography-cardiac output cohort

Adult patients who underwent surgery under general anesthesia with capnography and invasive arterial blood pressure monitor

Other: No Intervention: Observational Cohort

Interventions

No intervention

capnography-cardiac output cohort

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient who underwent surgery under general anesthesia in Samsung Medical Center, Seoul, South Korea

You may qualify if:

  • Elective surgery under general anesthesia
  • Adult patients (18 \< age \< 76)
  • Patients who were monitored invasive arterial blood pressure (waveform) and capnography (numeric)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Central Study Contacts

Heejoon Jeong, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 11, 2025

Study Start

July 3, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations