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非心脏手术的团队熟悉和围手术期结果

2026年8月23日 更新者:Peng Zhendan、Zhongda Hospital

团队熟悉对手术结果和患者安全性在非心脏手术中的影响

这项回顾性观察性研究的目的是量化团队协作对非心脏手术团队中手术室和患者安全结果的工作效率的影响。 主要目的是回答:

在手术期间/之后,团队协作如何影响手术室和患者安全结果的工作效率? 数据将从医院电子病历信息系统中获得,参与者已经完成了所有计划的手术。

研究概览

详细说明

这项研究旨在揭示团队合作在外科手术中的关键作用。 首先,通过计算手术团队内的协作程度,我们量化了团队成员之间的互动,沟通和信任,并随后分析了这种协作对手术团队工作效率指标的影响,包括麻醉前准备时间,麻醉时间和操作时间和操作时间,以确定最佳实践。 其次,它分析了手术团队之间的合作程度如何影响患者安全指标,例如术中失血,计划外次级手术的发生率和院内死亡率,从而揭示了团队工作对患者安全的直接或间接贡献。 还分析了手术团队规模,性别组成和转移模式对工作效率和患者安全指标的影响。

研究类型

观察性的

注册 (实际的)

69325

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Jiangsu
      • Nanjing、Jiangsu、中国、210009
        • Zhongda Hospital, Southeast University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

该研究人群包括2016年1月1日至2025年3月31日之间在张达医院东南大学接受程序的选修外科手术患者及其各自的外科团队成员。

描述

纳入标准:

  • 成人的所有选修手术(年龄≥18岁)

排除标准:

  • 患者人口统计学(年龄,性别),ASA等级,程序详细信息和位置数据的手术是无法获得的
  • 心脏外科手术(与固定手术团队)
  • 在非插管全身麻醉或静脉麻醉下的手术(主要是不需要密切多学科协作的诊断程序)
  • 手术病例缺少有关麻醉前准备时间,麻醉时间和手术持续时间的数据
  • 手术病例缺少有关团队成员多年经验和性别信息的数据。
  • 手术病例缺少有关术中和术后重大并发症和其他与安全有关的结果指标的数据

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Non-Cardiac Surgery Cohort
Adult patients undergoing elective non-cardiac surgery. Operating room team familiarity will be quantified using the Intraoperative Familiarity Score (IFS), and its association with perioperative outcomes will be evaluated.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Operating Room Team Efficiency
大体时间:During the index surgical procedure, assessed up to 24 hours

Operating room team efficiency is assessed by three workflow time intervals:

  1. pre-anesthesia preparation time, defined as the interval from patient arrival in the operating room to anesthesia initiation;
  2. anesthesia induction time, defined as the interval from anesthesia initiation to surgery start;
  3. surgical duration, defined as the interval from surgery start to surgery completion.

All time intervals are measured in minutes based on timestamps recorded in the anesthesia information management system.

During the index surgical procedure, assessed up to 24 hours

次要结果测量

结果测量
措施说明
大体时间
Estimated Intraoperative Blood Loss
大体时间:During the index surgical procedure, assessed up to 24 hours
Total estimated blood loss during surgery, recorded in milliliters (mL) from anesthesia and surgical records.
During the index surgical procedure, assessed up to 24 hours
Duration of Post-Anesthesia Care Unit (PACU) Stay
大体时间:From transfer from the operating room to the PACU until transfer from the PACU to the ward after the index surgery, assessed up to 12 hours
The duration of PACU stay, defined as the time interval from admission to discharge from the post-anesthesia care unit, recorded in minutes.
From transfer from the operating room to the PACU until transfer from the PACU to the ward after the index surgery, assessed up to 12 hours
Postoperative ICU Admission
大体时间:From completion of the index surgical procedure until hospital discharge, assessed up to 90 days
Whether the participant was admitted to the intensive care unit after the index surgery (yes/no), including direct transfer from the operating room to the ICU without PACU recovery, identified from postoperative medical records.
From completion of the index surgical procedure until hospital discharge, assessed up to 90 days
Duration of ICU Stay
大体时间:From postoperative ICU admission until ICU discharge or transfer to the ward during the index hospitalization (recorded as 0 days if no ICU admission), assessed up to 90 days
Length of postoperative ICU stay in days. Participants not admitted to the ICU are recorded as 0 days; for those admitted (including direct transfer from the operating room to the ICU), duration is measured from ICU admission until ICU discharge or transfer to the ward.
From postoperative ICU admission until ICU discharge or transfer to the ward during the index hospitalization (recorded as 0 days if no ICU admission), assessed up to 90 days
Unplanned Secondary Surgery Within 31 Days After Surgery
大体时间:From the day of the index surgical procedure, assessed up to 31 days
Occurrence of an unplanned secondary surgical procedure within 31 days after the index surgery, identified from hospital surgical records.
From the day of the index surgical procedure, assessed up to 31 days
In-Hospital Mortality
大体时间:From the day of the index surgical procedure until hospital discharge, assessed up to 90 days
Death occurring during the index hospitalization after surgery, identified from hospital medical records.
From the day of the index surgical procedure until hospital discharge, assessed up to 90 days
Unplanned Hospital Readmission Within 31 Days After Surgery
大体时间:From the day of the index surgical procedure, assessed up to 31 days
Occurrence of an unplanned hospital readmission within 31 days after the index surgical procedure, defined as an unexpected inpatient admission after discharge from the index hospitalization and identified from hospital medical records.
From the day of the index surgical procedure, assessed up to 31 days
Length of Hospital Stay
大体时间:From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days
Total duration of hospitalization, measured in days, from hospital admission to discharge after the index surgical procedure.
From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days
Total Hospitalization Cost
大体时间:From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days
Total hospitalization expenses associated with the index surgical procedure, recorded in Chinese Yuan (CNY) based on hospital billing records.
From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年7月7日

初级完成 (实际的)

2026年1月30日

研究完成 (实际的)

2026年1月30日

研究注册日期

首次提交

2025年6月6日

首先提交符合 QC 标准的

2025年7月3日

首次发布 (实际的)

2025年7月15日

研究记录更新

最后更新发布 (实际的)

2026年8月25日

上次提交的符合 QC 标准的更新

2026年8月23日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2025ZDSYLL172-P01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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