- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Hongbo Zheng, MM
- 전화번호: +8618040544926
- 이메일: zheng1283@163.com
연구 연락처 백업
- 이름: Hong Chen Chen, MM
- 전화번호: 17786127071
- 이메일: 2010tj0573@hust.edu.cn
연구 장소
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Hubei
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Wuhan, Hubei, 중국, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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연락하다:
- Hongbo Zheng, MM
- 전화번호: +8618040544926
- 이메일: zheng1283@163.com
-
연락하다:
- 이메일: zheng1283@163.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Epidural depth
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adjusted R²
기간: 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)
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Hongbo Zheng, MM, Tongji Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- EDPN
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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