Anesthesia, General, Fluid Responsiveness Predictability, Hemodynamic Monitoring
Conditions
Keywords
Fluid Responsiveness, Hemodynamic Monitoring
Brief summary
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: * Can the Acoustic Variability Index (AVI) measured by ResQ predict if a participant needs more fluids as accurately as the standard arterial blood pressure-based method (PPV)? * Is the ResQ device safe to use during surgery? Researchers will compare the new method (AVI) to the standard method (PPV) to see if ResQ provides reliable information for managing patient fluids. Participants will: * Undergo their planned surgery as scheduled. * Have a soft probe placed in the esophagus to monitor heart and lung sounds. * Receive a set amount of intravenous (IV) fluid as part of their regular surgery care. * Have their heart function checked before and after the fluids are given.
Interventions
DEVICEBiological Signal Processing Device for Acoustic Variability Index
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.
DEVICEPatient monitor for pulse pressure variation
A standard multi-parameter patient monitor used to measure the reference hemodynamic index, Pulse Pressure Variation (PPV), via an arterial catheter
DEVICEHemodynamic monitor for cardiac Output and stroke volume variation
A specialized hemodynamic monitoring system used to measure the reference standard for fluid responsiveness: Cardiac Output (CO) and Stroke Volume Variation (SVV)
DEVICEPatient monitor for pleth variability index
A patient monitoring system used to measure the Pleth Variability Index (PVI) via a non-invasive sensor attached to the finger or toe
DEVICEAnesthesia monitoring system for respiratory rate
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
Sponsors
Signal House Co., Ltd.
Ministry of SMEs and Startups, Korea
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To participate in this study, individuals must meet all of the following criteria: * Adults aged 19 years or older. * If female, not pregnant or breastfeeding. * Scheduled for a planned surgery of major organs in the abdominal, retroperitoneal, or pelvic cavities (e.g., hepatobiliary and pancreatic, small intestine, large intestine, kidney, uterus) under general anesthesia with mechanical ventilation * Classified as American Society of Anesthesiologists (ASA) Class I, II, or III. (Note: Excluded regardless of class if any
Exclusion criteria
are met) * Scheduled to receive mechanical ventilation in a volume-controlled or pressure-controlled mode in the operating room or intensive care unit, with an anticipated tidal volume of 6-8 mL/kg (Ideal Body Weight), respiratory rate of 8-14 breaths/min, and PEEP of 0-5 cmH2O * Scheduled for hemodynamic monitoring to measure the comparison indices during surgery * Able to understand the study's purpose and procedures and communicate clearly with the investigator and research staff * Voluntarily signed the written informed consent form before participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and PPV for Predicting Fluid Responsiveness (Non-inferiority) | Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance of Respiratory Rate (RR) between ResQ and Carestation 750 | Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge. | Assessed by evaluating the agreement of respiratory rate (RR) measurements between the ResQ device and the reference anesthesia workstation (Carestation 750). |
| Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and PVI for Predicting Fluid Responsiveness | Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge. | 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. |
| Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and SVV for Predicting Fluid Responsiveness | Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge | 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. |
| Diagnostic performance of AVI for fluid responsiveness (Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value) | Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge | 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. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORHye-Mee Kwon, MD, PhD
Asan Medical Center
Outcome results
None listed