Asan Medical Center
Seoul, 05505, South Korea
NCT Number: NCT07516470
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.
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Notify Me19 year and older
All sexes
Observational
Seoul, 05505, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
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.
Other names: SH-ResQ-01, ResQ
A standard multi-parameter patient monitor used to measure the reference hemodynamic index, Pulse Pressure Variation (PPV), via an arterial catheter
Other names: GE CARESCAPE Monitor B850
A specialized hemodynamic monitoring system used to measure the reference standard for fluid responsiveness: Cardiac Output (CO) and Stroke Volume Variation (SVV)
Other names: Edwards HemoSphere Monitor
A patient monitoring system used to measure the Pleth Variability Index (PVI) via a non-invasive sensor attached to the finger or toe
Other names: Masimo Root Monitor
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
Other names: GE Carestation 750
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Signal House Co., Ltd.
Industry
A Prospective, Single-Center, Single-Arm, Paired-Comparison, Open-Label, Non-Inferiority Confirmatory Trial to Evaluate the Efficacy and Safety of ResQ by Comparing Fluid Responsiveness Prediction Performance of the Acoustic Variability Index (AVI) Versus Pulse Pressure Variation (PPV) in Mechanically Ventilated Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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