- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07697053
Predictors of Epidural Depth in Percutaneous Nephrolithotomy and Model Development
Analysis of Factors Influencing Epidural Depth in Patients Undergoing Percutaneous Nephrolithotomy and Development of a Predictive Model
Обзор исследования
Статус
Подробное описание
Percutaneous nephrolithotomy (PCNL) is the standard minimally invasive surgical procedure for removal of kidney stones larger than 2 cm and is established as the gold standard for the management of complex renal calculi. This procedure may be performed under either general anesthesia or regional anesthesia, including epidural or spinal anesthesia. Accumulating meta-analyses have demonstrated that, compared with general anesthesia, regional anesthesia is associated with reduced postoperative pain scores and lower total hospital costs, without compromising the stone-free rate. Furthermore, in awake patients undergoing regional anesthesia, respiratory movements may generate a so-called "respiratory-synchronous stone fragmentation effect," which facilitates the expulsion of stone debris.
Successful epidural anesthesia relies critically on accurate identification of the epidural space and precise control of puncture depth. Insufficient puncture depth may result in improper catheter placement and subsequent block failure, whereas excessive puncture depth increases the risk of dural puncture, leading to cerebrospinal fluid leakage and post-dural puncture headache. In severe cases, inadvertent injection of a large dose of local anesthetics into the subarachnoid space can cause life-threatening cardiovascular and respiratory depression. Therefore, preprocedural estimation of the skin-to-epidural space distance is of considerable clinical importance.
Although racial differences in epidural depth have been reported, systematic investigations specifically targeting the Chinese population remain scarce. Various imaging modalities, including computed tomography, magnetic resonance imaging, and ultrasound, can be used to predict epidural depth. However, these examinations increase healthcare burden and are not always feasible in emergency or bedside settings. Consequently, identifying simple, easily obtainable clinical parameters-such as sex, age, and body mass index (BMI)-for predicting epidural depth has become a research priority.
In this context, the present study aimed to identify factors influencing epidural depth through a retrospective analysis of clinical data from PCNL patients and to develop simple, level-specific predictive models for different puncture sites, thereby providing a practical reference for clinical epidural anesthesia.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Hongbo Zheng, MM
- Номер телефона: +8618040544926
- Электронная почта: zheng1283@163.com
Учебное резервное копирование контактов
- Имя: Hong Chen Chen, MM
- Номер телефона: 17786127071
- Электронная почта: 2010tj0573@hust.edu.cn
Места учебы
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Hubei
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Wuhan, Hubei, Китай, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Контакт:
- Hongbo Zheng, MM
- Номер телефона: +8618040544926
- Электронная почта: zheng1283@163.com
-
Контакт:
- Электронная почта: zheng1283@163.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Age ≥ 18 years
- Successful epidural puncture and catheter placement using the midline approach
- Clear documentation of puncture level and puncture depth in the anesthesia record
Exclusion Criteria:
- Dural puncture during anesthesia (including those who subsequently had a successful repuncture)
- Use of the paramedian approach for epidural puncture
- Uncertain epidural anesthesia effect requiring combined general anesthesia
- Incomplete clinical data
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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T11-T12
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry).
Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated.
After positioning in the lateral decubitus position, the T11-T12 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry.
Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
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T12-L1
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry).
Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated.
After positioning in the lateral decubitus position, the T12-L1 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry.
Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
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L1-L2
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry).
Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated.
After positioning in the lateral decubitus position, the L1-L2 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry.
Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
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L2-L3
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry).
Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated.
After positioning in the lateral decubitus position, the L2-L3 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry.
Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Epidural depth
Временное ограничение: Perioperative/Periprocedural
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Epidural depth, defined as the vertical distance from the skin surface to the epidural space measured at the time of puncture using the loss-of-resistance technique via the midline approach.
Depth was recorded from the needle shaft markings to the nearest 0.1 cm.
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Perioperative/Periprocedural
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Adjusted R²
Временное ограничение: through study completion, an average of 1 month
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The coefficient of determination adjusted for the number of predictors in the model, reflecting the proportion of variance in epidural depth explained by the predictive model at each puncture level.
Higher values indicate better model fit.
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through study completion, an average of 1 month
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Root mean square error (RMSE)
Временное ограничение: through study completion, an average of 1 month
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The square root of the average squared difference between the model-predicted epidural depth and the actual measured depth, expressed in cm.
Lower values indicate better predictive accuracy of the model at each puncture level.
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through study completion, an average of 1 month
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Hongbo Zheng, MM, Tongji Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- EDPN
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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