Anaesthetic Management Guided by Cellular Oxygen Metabolism Measurements in Abdominal Surgery: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Mean mitoPO2 during abdominal surgery over time
研究概览
简要总结
Surgical site infection (SSI) is a significant cause of morbidity and mortality, prolonged hospital stays and healthcare costs. Perioperative low tissue oxygen tension is associated with a high risk of SSI. Standard anaesthetic management guided by continuous monitoring of oxygen delivery with a non-invasive method of measuring mitochondrial oxygenation tension (mitoPO2) using the Cellular Oxygen METabolism (COMET) monitor may benefit the intraoperative oxygenation on the tissue level. This randomised, controlled, single-centre, parallel-arm, patient-blinded trial aims to investigate if standard anaesthetic management guided by mitoPO2 monitoring results in higher tissue oxygen tension including patients undergoing elective abdominal surgery. Anaesthetists in the intervention group strive to a minimum mitoPO2 of 66 mmHg. Patients in the control group receive standard care. The primary outcome is the difference in means of the mean mitoPO2 during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The mitoPO2 in the control group is covered and made invisible to the anaesthetists. During the procedure, the outcome assessor is present to troubleshoot the device when needed and is also not blinded. Patients, surgeons and healthcare professionals during the postoperative period are blinded to the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients are at least 18 years old
- •Patients undergo elective open or laparoscopic abdominal surgery with an expected minimal total incision size of 5 cm
- •Patients are able and willing to give written informed consent
排除标准
- •Known photodermatoses of varying pathology and frequency
- •Mitochondrial disease
- •Porphyria
- •Skin lesions on the upper arm which impede measurements
- •Hypersensitivity to the active substance or the 5-ALA medicated plaster material
- •Emergency surgery
- •Reoperation for complications from recent surgery (within last three months)
- •Participation in another study with interference with this study
- •Pregnancy or breastfeeding
结局指标
主要结局
Mean mitoPO2 during abdominal surgery over time
时间窗: during surgery
Absolute difference between the means of the mean mitoPO2
次要结局
- MitoPO2 above baseline(during surgery)
- Exploration analysis of the correlation coefficients between the intraoperative mitoPO2 and the intraoperative monitoring measurement values(during intraoperative anaesthetic procedure)
- Surgical site infection(30 days follow-up)
- The respective effect per intervention in mitoPO2 after notification in which mitoPO2 aids decision making on anaesthetic management(during intraoperative anaesthetic procedure)
- Effect when using the COMET in sequentially treated patients in mitoPO2 assessed with a mixed effects model(during surgery)
研究者
Rick Hulskes
Study coordinator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)