Perioperative Pulmonary Monitoring in Major Emergency Surgery -the PROMIES Project
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Length of surgical incision
研究概览
简要总结
- Describe the incidence of postoperative hypoxemia after major emergency abdominal surgery as well as correlate this to clinical outcomes.
- Investigate the association between postoperative pulmonary complications and respiratory muscle dysfunction.
- Investigate the association between the length and type of incision as well as the distance to the xiphoid process and respiratory muscle dysfunction.
- Investigate the association between postoperative hypoxemia, myocardial ischemia and ischemic electrocardiographic (ECG) changes within three days of major emergency abdominal surgery
- Describe the incidence of postoperative cardiac arrhythmias within three days of major emergency abdominal surgery and the association with postoperative cardiovascular complications within 30 days, 90 days and 1 year of surgery.
- Describe the association between HRV and postoperative cardiovascular and non-cardiovascular complications within 30 days, 90 days and 1 year of surgery
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
- •Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
- •Major gastrointestinal surgery on the gastrointestinal tract.
- •This will include:
- •Open, laparoscopic, or laparoscopically-assisted procedures
- •Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischemia, abdominal abscess, bleeding or obstruction
- •Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis - excluded, see below)
- •Washout/evacuation of intra-peritoneal hematoma
- •Bowel resection/repair due to incarcerated umbilical, inguinal and femoral hernias (but not hernia repair without bowel resection/repair)
- •Bowel resection/repair due to obstructing/incarcerated incisional hernias provided the presentation and findings were acute
- •Laparotomy/laparoscopy with inoperable pathology (e.g. peritoneal/hepatic metastases)
- •Laparoscopic/Open adhesiolysis
- •Return to theatre for repair of fascial dehiscence
- •Any reoperation/return to theatre meeting the criteria above is included
- •If multiple procedures (primary surgery or reoperation) are performed on different anatomical sites within the abdominal/pelvic cavity, the patient would be included if the major procedure is general surgical.
排除标准
- •Not capable of giving informed consent after oral and written information
- •Previously included in the trial
- •Elective laparoscopy
- •Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
- •Appendectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
- •Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract (All surgery involving the appendix or gallbladder, including any surgery relating to complications such as abscess or bile leak is excluded)
- •Non-elective hernia repair without bowel resection.
- •Minor abdominal wound dehiscence unless this causes bowel complications requiring resection
- •Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
- •Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma
- •Laparotomy/laparoscopy for esophageal pathology
- •Laparotomy/laparoscopy for pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract
结局指标
主要结局
Length of surgical incision
时间窗: Day 1
The length of the surgical incision \[cm\] will be measured on the first postoperative day
Heart Rate Variability (HRV)
时间窗: 3 days
HRV assessed preoperatively - POD3, if this is not achievable then from POD0 - POD3
The occurence of per- and postoperative cardiac arrhythmias (until POD3)
时间窗: 3 days
The occurence of postoperative cardiac arrhythmia the first three days following surgery, with cardiac arrhythmia defined as: * Atrial fibrillation (AF) or * Atrial Flutter (AFL) or * Ventricular Tachycardia (VT- both monomorphic and polymorphic types) or * Recurrent sustained ventricular tachycardia (RSVT) or * Ventricular fibrillation (VF) or * Torsade de Pointes (TDP) or * 2nd degree atrioventricular (AV) block or * 3rd degree atrioventricular (AV) block
The occurence of postoperative hypoxemia during the first three postoperative days
时间窗: 3 days
The occurence of postoperative hypoxemia during the first three postoperative days, defined as: * the number of declines in saturation of 4 % (or more) lasting 20 seconds (or more) or * number of desaturation episodes below 90 % or * time (minutes( spent below 90 %,
Change in postoperative maximal inspiratory mouth pressure from POD1 to POD3
时间窗: 3 days
Maximal inspiratory mouth pressure \[cmH2O\] is measured on the first and third postoperative day to asses the change
Change in postoperative maximal expiratory mouth pressure from POD1 to POD3
时间窗: 3 days
Maximal expiratory mouth pressure \[cmH2O\] is measured on the first and third postoperative day to asses the change
The occurence of per- and postoperative ischemic ECG changes (until POD3)
时间窗: 3 days
The occurence of per- and postoperative ischemic ECG changes the first three days following surgery, defined as: * ST-depression ≥ 0,5 mm at the J-point in ≥ 2 contiguous leads or * Inverted T waves ≥ 1 mm in ≥2 contiguous leads that have dominant R waves or * ST-elevation ≥ 1 mm in ≥ 2 contiguous leads, however * ST-elevation in V2-V3 ≥ 2,5 mm for males \< 40 years of age in ≥ 2 contiguous leads * ST-elevation in V2-V3 ≥ 2,0 mm for males ≥ 40 years of age in ≥ 2 contiguous leads * ST-elevation in V2-V3 ≥ 1,5 mm for females in ≥ 2 contiguous leads) or * In V2-V3: Any q wave ≥ 0,02 seconds, * In other leads: Q wave ≥ 0,03 seconds and \> 1 mm deep in ≥ 2 contiguous leads.
次要结局
未报告次要终点