Actively Recruiting
Comparison of Acoustic Variability Index (AVI) and Pulse Pressure Variation (PPV) for Predicting Fluid Responsiveness in Mechanically Ventilated Patients
Led by Signal House Co., Ltd. · Updated on 2026-04-29
122
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
Sponsors
S
Signal House Co., Ltd.
Lead Sponsor
M
Ministry of SMEs and Startups, Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparison of Acoustic Variability Index (AVI) and Pulse Pressure Variation (PPV) for Predicting Fluid Responsiveness in Mechanically Ventilated Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Female participants must not be pregnant or breastfeeding
- Scheduled for planned surgery on major organs in the abdominal, retroperitoneal, or pelvic cavities under general anesthesia with mechanical ventilation
- Classified as American Society of Anesthesiologists (ASA) Class I, II, or III
- Scheduled to receive mechanical ventilation with specific settings: volume-controlled or pressure-controlled mode, 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 during surgery
- Able to understand study purpose and communicate clearly
- Provide written informed consent voluntarily
You will not qualify if you...
- Undergoing emergency or unplanned surgery
- Expected difficulty with general anesthesia or mechanical ventilation
- Expected massive bleeding of 1 L or more during surgery
- Undergoing reoperation for the same disease
- History of severe esophageal damage making probe insertion difficult
- Unable to have an arterial catheter inserted for SVV and PPV measurement
- Fluid challenge contraindicated or high risk (e.g., fluid overload, pulmonary congestion or edema, acute heart failure or renal failure, unstable hemodynamics)
- Body Mass Index (BMI) over 30 kg/m²
- Uncontrolled coagulopathy before surgery (e.g., low platelet count or high INR)
- Heart arrhythmias like atrial fibrillation/flutter or frequent premature contractions (>2 per 10 seconds)
- Other cardiovascular conditions preventing accurate cardiac output measurement
- Pregnant or breastfeeding women
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, Seoul, South Korea, 05505
Actively Recruiting
Research Team
H
Hye-Mee Kwon, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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