NCT07516470

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 122 (estimated)
• Sponsor: Signal House Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fluid Responsiveness Predictability
• Hemodynamic Monitoring
• Anesthesia, General

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: South Korea