Association Between Postoperative Glucose Profile, Sleep and Heart Rate Variability and Postoperative Complications in Patients Undergoing Acute, Abdominal Surgery. A Prospective, Explorative Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Quality of Recovery-15 score
研究概览
简要总结
The purpose of the study is to investigate whether glucose profile, sleep disturbances and heart rate variability measured with wearable devices is associated with postoperative recovery and complications within 30 days after major emergency abdominal surgery.
The study is designed as an explorative, prospective cohort study. 40 patients undergoing major emergency abdominal surgery at Zealand's University Hospital Køge are included in the study, and inclusion occurs within 24 hours of end of surgery. Patients will be followed for 30 days, and three scheduled study visits are planned during follow up at postoperative day 10, 20 and 30.
Glucose is measured continuously with a wearable subcutaneous sensor (Dexcom G6). Glucose readings are validated in the perioperative setting using blood glucose measurements obtained with standard finger-pricks 3-5 times a day during hospitalization.
Actigraphy is used for assessing sleep- and activity patterns for the full study period.
Heart rate variation is measured with a compact Holter monitor. Furthermore, the study assesses patient-reported quality of recovery, glucose metabolism, nutritional status and mobility. Various data on demographics, peri- and postoperative data will be extracted from the electronic patient chart.
详细描述
Purpose:
The purpose of the study is to investigate the glucose-profile, HRV and sleep disturbances for 30 days after major emergency abdominal surgery using continues measurements with wearable devices. Secondly, the study investigates the association between glucose profile, HRV, sleep-disturbances, patient reported recovery and postoperative complications.
Design and study population:
The study is designed as a prospective, explorative cohort study applying repeated measures. Patients undergoing major emergency abdominal surgery at Zealand's University Hospital Køge are included. Included patients receive a standardized treatment regimen (Optimizing Major EmerGency Abdominal surgery, OMEGA), which has been established in the surgical department in order to reduce unnecessary waiting time and optimize and standardize treatment before, during and after major emergency abdominal surgery. The treatment regimen includes pre-operative antibiotics, I.V. fluid, pain and nausea treatment, nasogastric tube and prioritized, fast access to CT-scans and final surgical treatment.
Sample Size:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing major emergency abdominal surgery including laparotomy or laporoscopy. Indications include ileus, perforated hollow organ, intraabdominal bleeding, ischemia, wound dehiscence.
排除标准
- •Laparoscopic surgeries for diseases related to appendix, gall bladder or bile ducts are excluded, unless the procedure is converted to open surgery perioperative.
- •not understanding or speeking danish
- •cognitive dysfunction
- •chronic immobilization
- •pregnancy
- •diabetes (type I and II)
- •Permanent atrial fibrillation or pacemaker
结局指标
主要结局
Quality of Recovery-15 score
时间窗: 30 days
The score is based on 15 questions with a maximum total score of 150 indicating excellent patient-reported recovery
Sleep Efficiency
时间窗: 30 days
The ratio of the total sleep time compared to the total time spent in bed during 24 hours
Heart rate variation
时间窗: 7 days post discharge or maximum 14 days after surgery
Heart rate variation measured with wearable devices. Time domain measures are used.
Total Sleep Time
时间窗: 30 days
Total time of sleep during 24 hours, assessed with actigraphy
Mean amplitude of glucose excursions (MAGE)
时间窗: 30 days
Measure of within-day glycemic variability assessed with continues glucose monitoring
次要结局
- Wake after Sleep Onset (WASO)(30 days)
- Number of awakenings(30 days)
- Time in bed(30 days)
- Wake Time(30 days)
- Mean glucose level(30 days)
- Time in range(30 days)
- Derived coefficient of glucose variation (%CV)(30 days)