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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and PPV for Predicting Fluid Responsiveness (Non-inferiority)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Patient monitor for pleth variability index (Device)
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.
干预措施: Hemodynamic monitor for cardiac Output and stroke volume variation (Device)
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.
干预措施: Patient monitor for pulse pressure variation (Device)
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.
干预措施: Anesthesia monitoring system for respiratory rate (Device)
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.
干预措施: Biological Signal Processing Device for Acoustic Variability Index (Device)
结局指标
主要结局
Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and PPV for Predicting Fluid Responsiveness (Non-inferiority)
时间窗: 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.
次要结局
- Concordance of Respiratory Rate (RR) between ResQ and Carestation 750(Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge.)
- Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and PVI for Predicting Fluid Responsiveness(Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge.)
- Comparison of Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) between AVI and SVV for Predicting Fluid Responsiveness(Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge)
- Diagnostic performance of AVI for fluid responsiveness (Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value)(Baseline (assessed continuously for 3 minutes before fluid challenge) and 3 minutes after a 500 mL fluid challenge)