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Completed

NCT Number: NCT07516470

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

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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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

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:

  • 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

Exclusion criteria

Individuals meeting any of the following criteria will be excluded from participation:

  • Undergoing emergency or unplanned surgery
  • Anticipated to have difficulty with the application of general anesthesia or mechanical ventilation
  • Anticipated to experience massive bleeding of 1 L or more during surgery.
  • Undergoing a reoperation due to the same underlying disease
  • History of severe esophageal damage (e.g., esophageal varices or stricture) that makes inserting the probe difficult
  • Inability to have an arterial catheter inserted, making the measurement of Stroke Volume Variation (SVV) and Pulse Pressure Variation (PPV) difficult
  • Condition where a fluid challenge is contraindicated or considered high risk (e.g., clinical signs of fluid overload, pulmonary congestion, or pulmonary edema; acute exacerbation of heart failure or renal failure; or a hemodynamically unstable state)
  • Body Mass Index (BMI) greater than 30 kg/m²
  • Uncontrolled coagulopathy prior to surgery (e.g., Platelet count < 100,000/μL or INR > 2)
  • Arrhythmias, such as atrial fibrillation/flutter or premature atrial/ventricular contractions (>2 per 10 seconds), that make it difficult for the variability index to operate accurately
  • Other cardiovascular history that makes accurate cardiac output measurement impossible (e.g., severe valvular disease, history of intracardiac shunt surgery, or structural heart surgery)
  • Pregnant or lactating women
  • Any other condition deemed unsuitable for study participation by the investigator

Treatment and study plan

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.

Other names: SH-ResQ-01, ResQ

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

Other names: GE CARESCAPE Monitor B850

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)

Other names: Edwards HemoSphere Monitor

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

Other names: Masimo Root Monitor

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

Other names: GE Carestation 750

Primary outcomes

  1. Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and PPV for Predicting Fluid Responsiveness (Non-inferiority)

    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.

Secondary outcomes

  1. Concordance of Respiratory Rate (RR) between ResQ and Carestation 750

    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).

  2. Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and PVI for Predicting Fluid Responsiveness

    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.

  3. Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and SVV for Predicting Fluid Responsiveness

    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.

  4. Diagnostic performance of AVI for fluid responsiveness (Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value)

    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.

Sponsors and collaborators

Lead sponsor

Signal House Co., Ltd.

Industry

Collaborators

  • Ministry of SMEs and Startups, Korea

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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