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NOT YET RECRUITING
NCT07516470

Comparison of Acoustic Variability Index (AVI) and Pulse Pressure Variation (PPV) for Predicting Fluid Responsiveness in Mechanically Ventilated Patients

Sponsor: Signal House Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

122

Start Date

2026-04

Completion Date

2026-12

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DEVICE

Biological 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.

DEVICE

Patient 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

DEVICE

Hemodynamic 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)

DEVICE

Patient 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

DEVICE

Anesthesia 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

Locations (1)

Asan Medical Center

Seoul, Seoul, South Korea