Impact of an Anesthesia Care Handover-Checklist on Adverse Perioperative Outcome (AnCHor - Checklist) Pilot Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Composite of mortality, hospital readmission and major postoperative complications
研究概览
简要总结
The aim of the study is to collect information on feasibility and effect size of a confirmatory, prospective study with the question: Does a standardized checklist during intraoperative handover of anaesthesia care reduce the rate of postoperative complications?
详细描述
During clinical routine, intraoperative handover of anaesthesia care occurs frequently. This handover between two anaesthesiologists requires the transmission of all relevant information concerning the patient and the ongoing procedure. Studies regarding the influence of such handovers on patient outcome are inconclusive and mostly of retrospective nature. Some studies report a negative effect of handovers on patients mortality and outcome, however studies exist reporting no effect. A positive effect of intraoperative handovers as a result of a "second man" effect ist also possible. To increase handover quality, the German Society of Anaesthesiology and Intensive Care Medicine (DGAI) recommends the application of the situation, background, assessment and recommendation (SBAR) concept. Information are arranged in those four groups with the goal of structuring the handover and incorporating all relevant information. Studies show increased accuracy of transferred information and improved comprehensibility when using the SBAR concept. Whether an intraoperative handover according to the SBAR concept reduces the rate of postoperative complications is not yet investigated. Due to lack of information regarding feasibility and effect size, the investigators plan a prospective pilot study to answer these questions. Initially, patients undergoing major surgery are recruited where handover is performed without a standardized handover. After the implementation of a checklist using the SBAR concept, this checklist will be used during intraoperative handover in recruited patients where a handover occurs. The primary endpoint is a combined endpoint consisting of all-cause mortality, readmission to any hospital, or major postoperative complications. Additionally, implementation rate and efficacy of the checklist will be evaluated.
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
- •Age ≥ 18 years
- •Major surgeries with a duration of at least 2 h (requirement of postoperative admission to hospital for at least 1 night)
- •American Society of Anesthesiologists (ASA) Classification 3-4
- •Informed consent
排除标准
- •Patients incapable of consent
- •Previous surgery within the same surgical subgroup within the last 6 months
- •Pregnancy, breastfeeding
- •Patients participating in another interventional trial within the last 3 months with possible interference to the outcome of this study
- •Persons with any kind of dependency on the investigator or employed by the investigator
结局指标
主要结局
Composite of mortality, hospital readmission and major postoperative complications
时间窗: within 30 days of index surgery
Number of patients that die and/or are readmitted to any hospital and/or experience any of the following: prolonged postoperative ventilation \>48 hours, major disruption of surgical wound, bleeding, pneumonia, atrial fibrillation, moderate or severe acute kidney injury, new onset of hemodialysis, cardiac arrest, myocardial infarction, sepsis, stroke, pulmonary embolism, deep venous thrombosis, shock, unplanned return to operating room
次要结局
- ICU admission(within 30 days of index surgery)
- Determination of recruitment rate(within 30 days of index surgery)
- Occurrence of moderate or severe acute kidney injury(within 30 days after index surgery)
- Shock(during the initial surgical procedure and within 30 days after index surgery)
- Implementation of checklist(on day of index surgery)
- Intra-abdominal abcess(within 30 days of index surgery)
- Myocardial infarction(during index surgery and within 30 days after index surgery)
- Pulmonary embolism and deep venous thromboembolism(within 30 days of index surgery)
- Need for intervention(within 30 days of index surgery)
- total morbidity(within 30 days of index surgery)
- Major disruption of surgical wound(within 30 days of index surgery)
- Cardiac arrest(within 30 days of index surgery)
- unplanned return to operating room(within 30 days of index surgery)
- Prolonged postoperative Ventilation >48 hours(within 48 hours after index surgery)
- New onset of hemodialysis(within 30 days after index surgery)
- Stroke(within 30 days of index surgery)
- Hospital length of stay(within 30 days of index surgery)
- ICU length of stay(within 30 days of index surgery)
- Bleeding(within the initial surgical procedure and within 30 days after index surgery)
- Insufficiency of anastomoses(within 30 days of index surgery)
- Pneumonia(within 30 days of index surgery)
- Atrial fibrillation(within 30 days of index surgery)
- Sepsis(within 30 days of index surgery)
- All-cause mortality(within 30 days of index surgery)
- Readmission to any hospital(within 30 days of index surgery)
研究者
Jan Larmann
Attending Anaesthesiologist
University Hospital Heidelberg