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| Name | Class |
|---|---|
| Ministry of SMEs and Startups, Korea | UNKNOWN |
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The goal of this clinical trial is to learn if a new medical device called ResQ works to predict fluid needs in adults undergoing surgery under general anesthesia. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanically Ventilated Surgical Patients (Paired-Comparison) | Adult patients (aged 19 years or older) scheduled for elective major abdominal, retroperitoneal, or pelvic surgery under general anesthesia and mechanical ventilation. In this single-arm, within-subject paired-comparison cohort, each participant undergoes real-time monitoring of hemodynamic indices-specifically the Acoustic Variability Index (AVI) and Pulse Pressure Variation (PPV)-both before and after a standardized 500 mL fluid challenge. This design allows for a direct comparison of the two indices within the same physiological state for each participant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological Signal Processing Device for Acoustic Variability Index | Device | A biosignal processing device that measures AVI and RR continuously in real-time. It analyzes heart and lung sounds collected via a general-purpose internal probe inserted into the patient's esophagus. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and PPV for Predicting Fluid Responsiveness (Non-inferiority) | Assessed by calculating and comparing the Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve for both indices to predict fluid responsiveness. The non-inferiority of AVI compared to PPV will be evaluated. Fluid responsiveness is defined as a Cardiac Output (CO) increase of 10% or more following a 500 mL fluid challenge. | Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance of Respiratory Rate (RR) between ResQ and Carestation 750 | Assessed by evaluating the agreement of respiratory rate (RR) measurements between the ResQ device and the reference anesthesia workstation (Carestation 750). | Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge. |
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Inclusion Criteria:
To participate in this study, individuals must meet all of the following criteria:
Exclusion Criteria:
Individuals meeting any of the following criteria will be excluded from participation:
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The study population consists of adult patients at Asan Medical Center in Seoul, South Korea. Participants will be recruited from the patients scheduled to undergo elective major surgeries involving organs in the abdominal, retroperitoneal, or pelvic cavities (such as hepatobiliary, pancreatic, intestinal, renal, or uterine procedures). These patients will be receiving general anesthesia and mechanical ventilation and are expected to require continuous intraoperative hemodynamic monitoring as part of their standard surgical care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hye-Mee Kwon, MD, PhD | Contact | +82-3010-1438 | hyemee.kwon@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hye-Mee Kwon, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Seoul | 05505 | South Korea |
A decision on whether to share Individual Participant Data (IPD) has not yet been made. The sponsor and investigators are currently evaluating the data sharing policy, and this record will be updated once a formal decision is reached.
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| Patient monitor for pulse pressure variation | Device | A standard multi-parameter patient monitor used to measure the reference hemodynamic index, Pulse Pressure Variation (PPV), via an arterial catheter |
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| Hemodynamic monitor for cardiac Output and stroke volume variation | Device | A specialized hemodynamic monitoring system used to measure the reference standard for fluid responsiveness: Cardiac Output (CO) and Stroke Volume Variation (SVV) |
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| Patient monitor for pleth variability index | Device | A patient monitoring system used to measure the Pleth Variability Index (PVI) via a non-invasive sensor attached to the finger or toe |
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| Anesthesia monitoring system for respiratory rate | Device | An anesthesia delivery and monitoring system used to provide the reference Respiratory Rate (RR) measurement based on end-tidal CO2 (EtCO2) waveforms during general anesthesia |
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| Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and PVI for Predicting Fluid Responsiveness | Assessed by calculating and comparing the Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve for both indices to predict fluid responsiveness. Fluid responsiveness is defined as a Cardiac Output (CO) increase of 10% or more following a 500 mL fluid challenge. | Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge. |
| Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and SVV for Predicting Fluid Responsiveness | Assessed by calculating and comparing the Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve for both indices to predict fluid responsiveness. Fluid responsiveness is defined as a Cardiac Output (CO) increase of 10% or more following a 500 mL fluid challenge. | Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge |
| Diagnostic performance of AVI for fluid responsiveness (Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value) | Assessed by calculating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) based on the optimal cut-off value determined by ROC curve analysis to evaluate the diagnostic performance of AVI. | Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D000074743 | Hemodynamic Monitoring |
| D002302 | Cardiac Output |
| D056152 | Respiratory Rate |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D006334 | Heart Function Tests |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
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