General Anesthesia Using Endotracheal IntubationNCT07061548
Algorithm Predicting Intraoperative Changes in Cardiac Output Using Capnography
An observational study of General Anesthesia Using Endotracheal Intubation, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- General Anesthesia Using Endotracheal Intubation
- How many people
- 2,005 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient who underwent surgery under general anesthesia in Samsung Medical Center, Seoul, South Korea
Who may be able to join
- Elective surgery under general anesthesia
- Adult patients (18 < age < 76)
- Patients who were monitored invasive arterial blood pressure (waveform) and capnography (numeric)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Heejoon Jeong, MD, +82-2-3410-0841, heejoonjeong@skku.edu
Heejoon Jeong, MD
About this study
Official title: Development of an Artificial Intelligence Model for Predicting Intraoperative Changes in Cardiac Output Using Capnography During General Anesthesia
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.
Read the 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.
- Being tested
- No Intervention: Observational Cohort
- Keywords
- artificial intelligence, general anesthesia, capnography, cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| capnography-cardiac output cohort | Adult patients who underwent surgery under general anesthesia with capnography and invasive arterial blood pressure monitor Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every time points with interval of 5 minutes during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start3 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthesia Using Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,005 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heejoon Jeong, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061548
- Sponsor's protocol ID
- SMC2025-06-120-001
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Artificial Intelligence Model for Predicting Intraoperative Changes in Cardiac Output Using Capnography During General Anesthesia
- ClinicalTrials.gov ID
- NCT07061548
- Acronym / sponsor ID
- SMC2025-06-120-001
- Keywords
- artificial intelligence, general anesthesia, capnography, cardiac output
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,005 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capnography-cardiac output cohort | – | Other: No Intervention: Observational CohortAdult patients who underwent surgery under general anesthesia with capnography and invasive arterial blood pressure monitor |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient who underwent surgery under general anesthesia in Samsung Medical Center, Seoul, South Korea
Key inclusion criteria (3 listed)
- Elective surgery under general anesthesia
- Adult patients (18 < age < 76)
- Patients who were monitored invasive arterial blood pressure (waveform) and capnography (numeric)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention | Other | capnography-cardiac output cohort |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia Using Endotracheal Intubation, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heejoon Jeong, MD (+82-2-3410-0841, heejoonjeong@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictability of algorithm (time frame: Every time points with interval of 5 minutes during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.