Actively Recruiting
Evaluation of the ResQ Device Comparing Fluid Responsiveness Prediction by Acoustic Variability Index Versus Pulse Pressure Variation in Mechanically Ventilated Surgical Patients
Led by Signal House Co., Ltd. · Updated on 2026-04-29
122
Participants Needed
1
Research Sites
8 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
Researchers are evaluating a new medical device called ResQ to see if it can predict fluid needs in adults undergoing surgery under general anesthesia. The study compares the Acoustic Variability Index (AVI) measured by ResQ with the standard Pulse Pressure Variation (PPV) method to determine if the device provides reliable information for managing fluids. The safety of ResQ during surgery is also being assessed. Participants scheduled for elective major abdominal, retroperitoneal, or pelvic surgery will undergo monitoring using the ResQ device and standard methods. A soft probe is placed in the esophagus to continuously measure heart and lung sounds, while pulse pressure variation is monitored via an arterial catheter. Participants receive a standardized 500 mL fluid challenge during surgery, allowing comparison of AVI and PPV before and after fluid administration. During the study, participants will have real-time monitoring of hemodynamic indices including heart function before and after receiving fluids. Researchers will assess the accuracy of AVI compared to PPV and other measures such as Pleth Variability Index (PVI) and Stroke Volume Variation (SVV). Safety and respiratory rate monitoring are also conducted. The primary outcome measures how well AVI predicts fluid responsiveness during surgery, with continuous assessments before and after fluid challenge.
CONDITIONS
Brief 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
- If female, not pregnant or breastfeeding
- Scheduled for planned major abdominal, retroperitoneal, or pelvic surgery 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 (tidal volume 6-8 mL/kg ideal body weight, respiratory rate 8-14 breaths/min, PEEP 0-5 cmH2O)
- Scheduled for hemodynamic monitoring during surgery
- Able to understand the study purpose and communicate with staff
- Voluntarily signed informed consent before participation
You will not qualify if you...
- Undergoing emergency or unplanned surgery
- Difficulty expected with general anesthesia or mechanical ventilation
- Expected massive bleeding of 1 liter or more during surgery
- Undergoing reoperation for the same disease
- History of severe esophageal damage making probe insertion difficult
- Unable to have arterial catheter inserted for monitoring
- Conditions where fluid challenge is contraindicated or high risk (e.g., fluid overload, pulmonary congestion, heart or renal failure, unstable hemodynamics)
- Body Mass Index (BMI) over 30 kg/m2
- Uncontrolled coagulopathy before surgery
- Arrhythmias interfering with variability index accuracy
- Other cardiovascular history preventing accurate cardiac output measurement
- Pregnant or lactating women
- Any other condition unsuitable for participation as decided by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the surgical procedure (several hours)
Participants undergo monitoring with several devices including the Acoustic Variability Index (AVI) device and pulse pressure variation (PPV) monitor during elective major surgery with general anesthesia and mechanical ventilation. Real-time measurements are taken before and after a standardized 500 mL fluid challenge to compare hemodynamic indices.
1 in-hospital visit during surgery
Duration - Up to the end of surgery day
Participants are observed to compare diagnostic performance of hemodynamic indices based on monitoring data collected during surgery.
No additional visits beyond surgery
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
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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