- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07643324
Normal vs Low Tidal Volume Ventilation in Retrograde Intrarenal Surgery
Comparison of Normal Ventilation and Low Tidal Volume Ventilation During Retrograde Intrarenal Surgery (RIRS) Using Video-Based Motion Index: A Randomized Controlled Trial
Retrograde intrarenal surgery is commonly performed under general anesthesia for the treatment of renal stones. During the procedure, respiratory-related renal movement caused by positive-pressure ventilation may impair endoscopic image stability and reduce the efficiency of laser lithotripsy. This randomized controlled trial aims to compare the effects of normal ventilation and low tidal volume ventilation on intraoperative endoscopic image stability during RIRS using a video-based Motion Index.
Eligible adult patients scheduled for elective RIRS under general anesthesia will be randomized in a 1:1 ratio to either normal tidal volume ventilation or low tidal volume ventilation. A standardized 60-second intraoperative video segment in which the stone and/or active laser lithotripsy is visible will be analyzed by blinded assessors. The primary outcome is the mean Motion Index value calculated from sequential video frames. Secondary outcomes include additional Motion Index parameters, laser activation time, anesthesia and surgical duration, intraoperative respiratory and hemodynamic safety parameters, vasopressor requirement, complications, and stone-free status at routine follow-up.
연구 개요
상세 설명
Retrograde intrarenal surgery (RIRS) is a minimally invasive endourological procedure widely used for the treatment of renal stones. Because the procedure is performed within the narrow collecting system of the kidney, endoscopic image stability is important for accurate laser targeting, efficient lithotripsy, and procedural safety. During general anesthesia, positive-pressure ventilation may cause diaphragmatic and respiratory-related renal movement, resulting in micro-movements of the endoscopic image. These movements may interfere with continuous laser targeting and may reduce procedural efficiency.
This study is designed as a single-center, prospective, randomized, parallel-group, assessor-blinded controlled trial. Adult patients scheduled for elective RIRS under general anesthesia will be enrolled after obtaining written informed consent. Participants will be randomized in a 1:1 ratio to one of two intraoperative ventilation strategies: normal tidal volume ventilation or low tidal volume ventilation. Randomization will be performed using a computer-generated randomization list, and allocation concealment will be ensured with sequentially numbered, opaque, sealed envelopes. The video assessors will be blinded to group allocation.
After induction of general anesthesia and endotracheal intubation, mechanical ventilation will be standardized according to the assigned group. In the normal ventilation group, tidal volume will be set at 6-8 mL/kg predicted body weight with 5 cmH₂O PEEP. In the low tidal volume ventilation group, tidal volume will be set at 4-6 mL/kg predicted body weight with 5 cmH₂O PEEP. In both groups, respiratory rate will be titrated to maintain EtCO₂ within the target range of 35-45 mmHg, and FiO₂ will be adjusted to maintain SpO₂ above 94%. Patient safety will take priority throughout the study, and ventilation settings may be modified if clinically required. Any protocol deviations will be recorded.
Intraoperative endoscopic videos obtained during routine RIRS will be used for the video-based analysis. After the procedure, video files will be anonymized and coded in a way that does not reveal group allocation. A standardized 60-second segment in which the stone is clearly visible and/or laser lithotripsy is active will be selected according to predefined criteria. The selected segments will be analyzed using a phase-correlation-based image registration method. Sequential video frames will be converted to grayscale, mild noise reduction will be applied, and horizontal and vertical image displacement between consecutive frames will be calculated. The Motion Index will be derived from these displacement components for each frame pair, generating a time series for each patient.
The primary outcome of the study is the mean Motion Index value calculated from the standardized intraoperative video segment. Secondary outcomes include additional Motion Index parameters, including median, 95th percentile, and maximum Motion Index values; laser activation time; anesthesia duration; surgical duration; intraoperative respiratory and hemodynamic parameters such as EtCO₂, SpO₂, mean arterial pressure, heart rate, airway pressures when available, and vasopressor requirement; perioperative complications; and stone-free status at routine postoperative follow-up, planned at approximately 4 weeks.
The study aims to determine whether low tidal volume ventilation improves endoscopic image stability during RIRS without compromising respiratory or hemodynamic safety. The findings may contribute to the standardization of anesthetic ventilation strategies during endourological stone surgery and may provide an objective, reproducible method for evaluating respiratory-related image motion during RIRS.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sibel Onen Ozdemir, MD
- 전화번호: +905442892194
- 이메일: sibelonen89@gmail.com
연구 장소
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Çorum, 터키 (Türkiye)
- 모병
- Hitit University
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연락하다:
- Ozgur Yagan, Professor
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adult patients aged 18 years or older
- Patients scheduled for elective retrograde intrarenal surgery under general anesthesia
- ASA physical status I-III
- Patients who are able to read and understand the informed consent form
- Patients who provide written informed consent
Exclusion Criteria:
- Patients younger than 18 years
- Pregnancy
- Emergency surgery
- Severe chronic obstructive pulmonary disease, severe restrictive pulmonary disease, or preoperative hypercapnia
- Severe uncontrolled cardiovascular disease
- Active urinary tract infection, sepsis, or untreated infectious focus
- Cases in whom the standardized ventilation protocol is difficult to apply because of morbid obesity
- Patients scheduled for an additional major urological procedure in the same session
- Cases in which an intraoperative video recording of sufficient quality cannot be obtained
- Patients in whom the study protocol cannot be safely continued according to the investigator's clinical judgment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Normal Tidal Volume Ventilation
Participants in this group will receive standard mechanical ventilation after induction of general anesthesia and endotracheal intubation during retrograde intrarenal surgery.
Tidal volume will be set at 6-8 mL/kg predicted body weight with 5 cmH₂O PEEP.
Respiratory rate will be titrated to maintain EtCO₂ between 35 and 45 mmHg, and FiO₂ will be adjusted to maintain SpO₂ above 94%.
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Participants allocated to the normal tidal volume ventilation group will receive volume-controlled mechanical ventilation during retrograde intrarenal surgery under general anesthesia.
Tidal volume will be set at 6-8 mL/kg predicted body weight with 5 cmH₂O PEEP.
Respiratory rate will be titrated to maintain EtCO₂ between 35 and 45 mmHg, and FiO₂ will be adjusted to maintain SpO₂ above 94%.
다른 이름들:
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실험적: Low Tidal Volume Ventilation
Participants in this group will receive low tidal volume mechanical ventilation after induction of general anesthesia and endotracheal intubation during retrograde intrarenal surgery.
Tidal volume will be set at 4-6 mL/kg predicted body weight with 5 cmH₂O PEEP.
Respiratory rate will be titrated to maintain EtCO₂ between 35 and 45 mmHg, and FiO₂ will be adjusted to maintain SpO₂ above 94%.
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Participants allocated to the normal tidal volume ventilation group will receive volume-controlled mechanical ventilation during retrograde intrarenal surgery under general anesthesia.
Tidal volume will be set at 6-8 mL/kg predicted body weight with 5 cmH₂O PEEP.
Respiratory rate will be titrated to maintain EtCO₂ between 35 and 45 mmHg, and FiO₂ will be adjusted to maintain SpO₂ above 94%.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Motion Index During Retrograde Intrarenal Surgery
기간: Intraoperative period, during a standardized 60-second video segment
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Mean Video-Based Motion Index will be calculated from a standardized 60-second intraoperative endoscopic video segment in which the stone is clearly visible and/or laser lithotripsy is active.
The Video-Based Motion Index is a unitless image-motion metric derived from horizontal and vertical frame-to-frame displacement between consecutive video frames using a phase-correlation-based image registration method.
The theoretical minimum value is 0, indicating no detected image displacement.
There is no predefined fixed maximum value because the value depends on the magnitude of frame-to-frame displacement.
Higher values indicate greater endoscopic image motion and worse image stability.
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Intraoperative period, during a standardized 60-second video segment
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-17
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
low tidal volume ventilation에 대한 임상 시험
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University of the Basque Country (UPV/EHU)HOSPITAL SANTIAGO APOSTOL. MIRANDA DE EBRO. BURGOS. SPAIN알려지지 않은