- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07635160
Assessment of Renal Perfusion Using Ultrasound and Near-Infrared Spectroscopy in Patients Undergoing Minimally Invasive Abdominal Surgery (RRI-NIRS)
Prospective Observational Evaluation of Renal Perfusion Using Doppler Ultrasonography and Near-Infrared Spectroscopy in Patients Undergoing Elective Minimally Invasive Abdominal Surgery
This prospective observational study aims to evaluate renal perfusion in adult patients undergoing elective minimally invasive abdominal surgery. Renal perfusion will be assessed using two non-invasive monitoring techniques: Doppler ultrasonography-derived Renal Resistive Index (RRI) and Near-Infrared Spectroscopy (NIRS)-derived renal regional oxygen saturation (rSO₂).
Measurements will be obtained at predefined perioperative time points, including after induction of anesthesia, during pneumoperitoneum, before extubation, and during the early postoperative period. Perioperative changes in renal perfusion parameters will be analyzed and correlated with clinical variables such as intra-abdominal pressure, pneumoperitoneum duration, hemodynamic parameters, fluid administration, urine output, and postoperative renal function.
The study also aims to investigate the relationship between intraoperative renal perfusion changes and the development of postoperative acute kidney injury. The findings may contribute to improved perioperative monitoring and optimization of renal perfusion during minimally invasive abdominal surgery.
연구 개요
상태
상세 설명
Minimally invasive abdominal surgery has become increasingly common because of reduced surgical trauma, faster recovery, and lower postoperative morbidity compared with conventional open surgery. However, laparoscopic procedures require the creation of pneumoperitoneum, which may increase intra-abdominal pressure and adversely affect renal blood flow, renal oxygen delivery, and kidney function.
Renal hypoperfusion during surgery may contribute to postoperative renal dysfunction and acute kidney injury (AKI). Traditional indicators of renal injury, such as serum creatinine and urine output, often fail to detect early changes in renal perfusion. Therefore, reliable non-invasive methods for real-time assessment of renal perfusion are needed.
Doppler ultrasonography-derived Renal Resistive Index (RRI) and Near-Infrared Spectroscopy (NIRS)-derived regional renal oxygen saturation (rSO₂) are promising techniques for evaluating renal perfusion and oxygenation. Both methods provide non-invasive, bedside assessment and may allow early detection of perfusion abnormalities before conventional markers become abnormal.
This prospective single-center observational study will evaluate perioperative renal perfusion in adult patients undergoing elective minimally invasive abdominal surgery. Renal perfusion measurements will be obtained using Doppler ultrasonography and NIRS at predefined perioperative time points, including after induction of anesthesia, during pneumoperitoneum, before extubation, and during the early postoperative period.
Demographic characteristics, comorbidities, baseline renal function, intraoperative hemodynamic variables, pneumoperitoneum duration and pressure, fluid administration, urine output, blood loss, ventilatory parameters, and postoperative renal function will be recorded. Associations between perioperative renal perfusion parameters and postoperative renal outcomes, including acute kidney injury, will be investigated.
The findings of this study may improve understanding of perioperative renal perfusion changes during minimally invasive abdominal surgery and contribute to the development of strategies for optimizing renal protection and perioperative patient management
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Lyudmila MARTYNENKO AYDOGDU, M.D.
- 전화번호: +90 5300613611
- 이메일: lyudmila.lylyly1@gmail.com
연구 장소
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Istanbul, 터키 (Türkiye), 34320
- 모병
- Istanbul University Cerrahpasa Faculty of Medicine
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연락하다:
- Lyudmila MARTYNENKO AYDOGDU, M.D.
- 전화번호: +90 5300613611
- 이메일: lyudmila.lylyly1@gmail.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:
- Patients aged 18 to 80 years
- Patients with ASA physical status I, II, or III
- Patients undergoing elective minimally invasive abdominal surgery for any reason
- Patients whose expected surgical duration is longer than 1 hour
Exclusion Criteria:
- Body mass index greater than 35 kg/m²
- Severe respiratory system disease
- Severe heart failure, NYHA class III-IV
- Presence of a cardiac pacemaker or cardiac defibrillator implant
- Progressive neuromuscular disease
- High intra-abdominal pressure
- Sudden deterioration of general condition
- Incomplete clinical or laboratory data
- Refusal to participate in the study
- Conversion to open surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Elective Minimally Invasive Abdominal Surgery Patients
Adult patients aged 18 to 80 years undergoing elective minimally invasive abdominal surgery under general anesthesia.
Renal perfusion will be assessed perioperatively and postoperatively(postoperative 1. hour) using Doppler ultrasonography-derived Renal Resistive Index (RRI) and Near-Infrared Spectroscopy (NIRS)-derived regional renal oxygen saturation (rSO₂).
Measurements will be performed at predefined perioperative time points and correlated with intraoperative variables, postoperative renal function, and the occurrence of acute kidney injury.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Renal Regional Oxygen Saturation Measured by NIRS
기간: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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Renal regional oxygen saturation (rSO₂) will be measured bilaterally using Near-Infrared Spectroscopy (NIRS).
NIRS values will be recorded at predefined perioperative time points.
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after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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Change in Renal Resistive Index
기간: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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Renal Resistive Index (RRI) measured by Doppler ultrasonography at predefined perioperative time points.
RRI will be calculated from peak systolic velocity and end-diastolic velocity obtained from renal interlobar or arcuate arteries.
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after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Relationship Between Renal Resistive Index and Renal Regional Oxygen Saturation
기간: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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The relationship between renal Doppler ultrasonography-derived Renal Resistive Index (RRI) and NIRS-derived renal regional oxygen saturation (rSO₂) will be evaluated for the right and left kidneys at predefined perioperative measurement time points.
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after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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공동 작업자 및 조사자
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
- CUC-RenalPerfusion-2026
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
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