- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02688946
Imaging Microcirculation and Gross Hemodynamics in Elective Colorectal Surgery (IMAGES)
Imaging Microcirculation And Gross Hemodynamic Assessment of the Bowel During Elective Colorectal Surgery
Rationale: The interaction between macro and microcirculation remains uncertain. Microvascular alterations can occur when systemic hemodynamic parameters are within an acceptable range. Perfusion changes and microvascular alterations may play an important role in anastomotic healing and the onset of anastomotic leakage after gastrointestinal surgery. Nowadays, assessment of bowel perfusion is macroscopically performed by the surgeon prior to anastomosis creation. However, local oxygen delivery may still be compromised as little is known about microcirculatory alterations of the bowel during colorectal surgery. Dark Field (DF) imaging is a technique using a stroboscopic light-emitting diode ring-based imaging modality incorporated in a hand-held device, which illuminates an area of interest and provides high contrast dynamic images of the microvasculature. DF-imaging enables to visualize the bowel's microcirculation.
Objective: To describe the human gastrointestinal microcirculation during gastrointestinal surgery under general anesthesia and to observe whether there is a correlation between bowel microcirculation and systemic hemodynamic parameters.
Study design: A prospective, single center, observational, clinical, pilot study.
Study population: 70 patients undergoing elective, gastrointestinal surgery during which the gastrointestinal tract is accessible for DF-imaging.
Main study parameters/endpoints: To describe human gastrointestinal microcirculation on both the serosal and mucosal side of the bowel during gastrointestinal surgery under general anesthesia. Main parameter: Microvascular perfusion is quantified using the Microvascular Flow Index (MFI).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The extend of burden and risk associated with participation is negligible. Using DF imaging on the bowel is a non-invasive technique requiring a minimal amount of time as is described in the study procedure. Previous studies did not show any safety concerns. Measuring will be performed under sterile conditions and the occurrence of tissue damage is highly unlikely. Patients are under general anesthesia and will thus not experience any inconvenience.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
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Nieuwegein, 네덜란드
- St Antonius Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
70 patients undergoing elective, gastrointestinal surgery. Surgical procedures included will be:
- All forms of open colorectal surgery;
- Pylorus Persevering PancreaticoDuodenectomy (PPPD);
- Other procedures requiring small bowel resection for cancer;
- Laparoscopic procedures with extracorporeal creation of the bowel anastomosis. These procedures provide unique access to different parts of the bowel. The PPPD procedure provides access to the mucosal and serosal side of the jejunum. Colorectal surgery provides access to both the serosal and mucosal side of the colon and the terminal ileum is sometimes also accessible. We expect to include around 2 patients per week.
설명
Inclusion Criteria:
- All patients aged >18 scheduled for elective, gastrointestinal surgery (as described above) with signed informed consent.
Exclusion Criteria:
• Age <18 years;
- Atrial fibrillation (because of possible interference with FloTrac™/Vigileo™ cardiac output monitor);
- Left ventricular ejection fraction ≤30%;
- Serious pulmonary disease (resting pO2 <90% at room air);
- Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula);
- Liver failure;
- No signed informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Microvascular flow index (MFI)
기간: Intra-operative
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During surgery
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Intra-operative
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Perfused vessel density (PVD)
기간: Intra-operative
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Intra-operative
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Proportion of perfused vessels (PPV)
기간: Intra-operative
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Intra-operative
|
|
Total vessel density (TVD)
기간: Intra-operative
|
Intra-operative
|
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Heterogeneity index (HI)
기간: During surgery
|
During surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mat Van Iterson, PhD, St. Antonius Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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
- NL4833210014
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
Not provided에 대한 임상 시험
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Ahram Canadian University아직 모집하지 않음흡연 | 구강 안면 기능 장애
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