跳至主要内容
临床试验/NCT04016454
NCT04016454已完成不适用

Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes

University Hospital Muenster13 个研究点 分布在 1 个国家目标入组 1,817 人开始时间: 2019年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,817
试验地点
13
主要终点
Combined endpoint consisting number of participants with all-cause mortality, readmission to any hospital or major postoperative complications

研究概览

简要总结

Our goal is to conduct a prospective, national, randomized-controlled, multicenter trial to investigate the effect of handover of anesthesia care on the occurrence of adverse outcomes in the perioperative period.

详细描述

Intraoperative handover of anesthesia care frequently occurs in clinical routine. Communication between the two anesthesiologists plays a pivotal role for the continuation of anesthesia care. The outgoing clinician must inform the incoming clinician in a short period of time about the important pre- and intraoperative facts and about the surgery while continuing to provide patient care. Contributing factors to inadequate communication during handoffs include insufficient or misleading information, busy and distractive environment, ineffective communication methods, lack of time, lack of standardized procedures, and insufficient staffing. It is estimated that the majority of adverse events in health care involve miscommunication during the handoff between physicians and perhaps other health care practitioners (https://www.jointcommission.org/hot_topics_toc/).

The goal is to conduct a prospective, national, randomized-controlled, multicenter trial to investigate the effect of handover of anesthesia care on the occurrence of adverse outcomes in the perioperative period. The investigators hypothesizes that handover of anesthesia care does increase the risk for adverse outcomes. The primary outcome parameter is a combined endpoint consisting of all-cause mortality, readmission to any hospital, or major postoperative complications (including prolonged postoperative ventilation ≥ 48 h, 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) within 30 days of index surgery. Secondary endpoints are the individual criteria of the primary endpoint, hospital length of stay, ICU admission, and ICU length of stay. As the currently available data on handover of anesthesia care have not been obtained from prospective, randomized controlled trials, the results of the Handicap trial will bring new insights to anesthesia care to improve patients' outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

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)
  • Informed consent

排除标准

  • 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
  • Persons with any kind of dependency on the investigator or employed by the investigator

结局指标

主要结局

Combined endpoint consisting number of participants with all-cause mortality, readmission to any hospital or major postoperative complications

时间窗: within 30 days of index surgery

次要结局

  • Number of participants with all-cause mortality(within 30 days of index surgery)
  • Numer of participants with readmission to any hospital(within 30 days of index surgery)
  • ICU length of stay(within 30 days of index surgery)
  • Number of participants with major postoperative complication(within 30 days of index surgery)
  • Hospital length of stay(within 30 days of index surgery)
  • Number of patients with ICU admission(within 30 days of index surgery)

研究者

发起方
University Hospital Muenster
申办方类型
Other
责任方
Sponsor

研究点 (13)

Loading locations...

相似试验