Stroke Clinical Trials

Find Stroke Clinical Trials Near You

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: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
Hye-Mee Kwon, MD, PhD
hyemee.kwon@amc.seoul.kr
+82-3010-1438
Time Frame
Start Date: 2026-04-13
Estimated Completion Date: 2026-12
Participants
Target number of participants: 122
Treatments
Mechanically Ventilated Surgical Patients (Paired-Comparison)
Adult patients (aged 19 years or older) scheduled for elective major abdominal, retroperitoneal, or pelvic surgery under general anesthesia and mechanical ventilation. In this single-arm, within-subject paired-comparison cohort, each participant undergoes real-time monitoring of hemodynamic indices-specifically the Acoustic Variability Index (AVI) and Pulse Pressure Variation (PPV)-both before and after a standardized 500 mL fluid challenge. This design allows for a direct comparison of the two indices within the same physiological state for each participant.
Related Therapeutic Areas
Sponsors
Leads: Signal House Co., Ltd.
Collaborators: Ministry of SMEs and Startups, Korea

This content was sourced from clinicaltrials.gov