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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSignal House Co., Ltd.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biological Signal Processing Device for Acoustic Variability Index
  • Patient monitor for pulse pressure variation
  • Hemodynamic monitor for cardiac Output and stroke volume variation
  • Patient monitor for pleth variability index
  • Anesthesia monitoring system for respiratory rate

Treatment groups

122 Participants
are divided into 1 treatment group

Sponsors and collaborators

Signal House Co., Ltd.

Lead sponsor

Ministry of SMEs and Startups, Korea

Collaborator