PVI Predictors in Laparoscopic Hysterectomy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Masimo Radical-7 Pulse Oximeter.
- Кому может быть актуально
- Состояния в реестре: Hysterectomy, PVI, Fluid Responsiveness. Базовые параметры: 19 лет — 70 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Predictors of Pleth Variability Index During Laparoscopically Assisted Vaginal Hysterectomy
Обзор
This observational study investigates the predictors of Pleth Variability Index (PVI) changes in euvolemic patients undergoing laparoscopic-assisted vaginal hysterectomy (LAVH). The primary objective is to quantify changes in PVI (ΔPVI) across six intraoperative time points associated with positional shifts. Secondary objectives include identifying key predictors of significant PVI change (ΔPVI ≥ 5%), such as passive leg raising, Trendelenburg position, body mass index (BMI), and intraabdominal pressure. Additional variables including perfusion index, mean arterial pressure, bispectral index, skin temperature, age, and anesthetic agent will be evaluated as potential modulators. Findings aim to support individualized fluid management strategies in LAVH.
Подробное описание
This prospective, single-center observational cohort study evaluates dynamic intraoperative changes in the Pleth Variability Index (PVI) in 50 adult female patients undergoing elective laparoscopically assisted vaginal hysterectomy (LAVH) at Wonkwang University Hospital.
After establishing euvolemia with a 500 mL Volulyte preload (Fresenius Kabi GmbH) over 30-50 minutes, no further intraoperative fluid boluses are given. Anesthesia is induced with propofol (2 mg/kg), fentanyl (1-2 μg/kg), and rocuronium (0.6 mg/kg), and maintained with sevoflurane or desflurane titrated to a bispectral index (BIS) of 40-60. Pneumoperitoneum is set at 12-15 mmHg, and positional maneuvers include 30° passive leg raising, 15° Trendelenburg, and 15° reverse Trendelenburg.
Monitoring devices and data acquisition:
* \*\*Masimo Radical-7\*\* pulse oximeter (PVI, perfusion index \[PI\]) * \*\*Invasive arterial line\*\* (mean arterial pressure \[MAP\]) * \*\*BIS sensor\*\* (BIS) * \*\*Skin temperature probe\*\* (forearm, °C) calibrated pre-case
Measurements are recorded at six standardized time points (baseline; post-induction; post-passive leg raising; post-pneumoperitoneum; post-Trendelenburg; post-reverse Trendelenburg). Continuous waveforms are averaged over 30 s epochs.
Primary endpoint is the absolute change in PVI (ΔPVI) relative to baseline. Secondary analyses include:
* Multivariable logistic regression for predictors of ΔPVI ≥ 5% * Multivariable linear regression for continuous ΔPVI prediction * Correlation analyses of ΔPVI with intraabdominal pressure (mmHg) and body mass index (kg/m²) * Sensitivity analysis of PI reliability (intraclass correlation coefficient) across skin temperature thresholds * Descriptive statistics for frequency of vasopressor (ephedrine) use
All analyses are performed using SPSS v29.0 with p \< 0.05 considered statistically significant (Bonferroni correction applied for repeated measures).
Вмешательства
- Устройство Masimo Radical-7 Pulse Oximeter
"PVI is continuously monitored using the Masimo Radical-7 pulse oximetry device to evaluate respiratory variation in the plethysmographic waveform amplitude during laparoscopic-assisted vaginal hysterectomy (LAVH). No fluid intervention is applied; device use is for observational measurement of fluid responsiveness."
Первичные конечные точки
- ΔPVI (Change in Pleth Variability Index) [Срок оценки: Intraoperative period (~60-90 minutes)]
Вторичные конечные точки (8)
- Proportion of patients with significant ΔPVI ≥ 5% [Срок оценки: At any of the six predefined intraoperative time points: • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg • End of surgery (within 60-90 minutes after induction of anesthesia)]
- Effect of intraabdominal pressure on ΔPVI [Срок оценки: At post-pneumoperitoneum and post-Trendelenburg time points (20-45 minutes after anesthesia induction)]
- Effect of body mass index on ΔPVI [Срок оценки: ΔPVI measured at post-pneumoperitoneum and post-Trendelenburg time points (20-45 minutes after anesthesia induction)]
- Change in mean arterial pressure (MAP) [Срок оценки: MAP measured at six predefined intraoperative time points: • Baseline • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg (Total duration: ~90 minutes after anesthesia induction)]
- Change in perfusion index (PI) [Срок оценки: MAP measured at six predefined intraoperative time points: • Baseline • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg (Total duration: ~90 minutes after anesthesia induction)]
- Change in bispectral index (BIS) [Срок оценки: MAP measured at six predefined intraoperative time points: • Baseline • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg (Total duration: ~90 minutes after anesthesia induction)]
- Influence of skin temperature on PI reliability [Срок оценки: MAP measured at six predefined intraoperative time points: • Baseline • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg (Total duration: ~90 minutes after anesthesia induction)]
- Frequency of vasopressor use [Срок оценки: MAP measured at six predefined intraoperative time points: • Baseline • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg (Total duration: ~90 minutes after anesthesia induction)]
Критерии участия
Критерии включения
- adult females aged 19-70 years (American Society of Anesthesiologists physical status I-III) scheduled for elective LAVH.
Критерии исключения
- emergency surgery, severe cardiac or pulmonary disease, renal failure, pregnancy, or conditions contraindicating fluid administration. Participants were consecutively recruited during preoperative consultations.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
South Korea · 1 центр
- Wonkwang University School of Medicine Hospital — Iksan
Идентификаторы
NCT: NCT06981221 · Wonkwang UH19