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Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery (SOMBATA)

2022年8月13日 更新者:Göteborg University

Background

Thoracic or abdominal surgeries are followed by a shorter or longer period of immobilization and after major surgery there is a higher risk of developing cardiorespiratory complications. To prevent these complications, the patient is encouraged to change position and exercise in bed, get out of bed as early and as much as possible after the operation and to breathe with or without aids. There is no general definition of early mobilization and may start within a few hours to a few days after surgery. There is currently a lack of knowledge nationally and internationally about when the mobilization starts and what it contains.

Many patients also receive breathing training in connection with the surgery. There is currently no consensus on which method is preferable for which groups of patients. There are similarities and differences in practice in the world regarding postoperative breathing training. There are studies that have mapped practice after primarily thoracic surgery but also abdominal surgery. However, there are no studies that have mapped when the prescribed breathing training starts after different types of operations.

The purpose of the study is to map when mobilization and breathing training starts after abdominal and thoracic surgery and what is then performed

Method The study will be carried out as a quality follow-up with mapping of practice. Patients ≥ 18 years of age who are undergoing a planned or acute open, keyhole or robot-assisted surgery, who are extubated and who breathe spontaneously will be included. Exclusion criteria are completed plastic, trauma, orthopedic or transplant surgery.

The material will be recruited from Swedish university hospitals and county hospitals for 20 days of surgery (Monday through Thursday) for five consecutive weeks.

Clinical benefit The study will mean that clinical practice is presented which, with regard to mobilization, is the first study ever that will present when this takes place and what is done and, with regard to breathing training, the first that shows when this training is initiated.

研究概览

地位

完全的

研究类型

介入性

注册 (实际的)

1492

阶段

  • 不适用

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

    • Västra Götaland
      • Göteborg、Västra Götaland、瑞典、41345
        • Sahlgrenska University Hospital

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • ≥ 18 years of age
  • undergoing a planned or acute open, laparoscopic or robot-assisted surgeon in the thorax or abdomen
  • who are extubated within 24 h of surgery
  • breathe spontaneously within 24 h of surgery

Exclusion Criteria:

  • reconstructive-, trauma-, transplantation- or orthopedic surgery.

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

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Mobilization and breathing training
Usual clinical care
Mobilization and breathing exercises according to clinical care
其他名称:
  • Breathing training

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
When mobilization starts after surgery
大体时间:Within 24 hours after surgery
Time from termination of anaesthesia to when mobilization starts, ie when the patients are sitting with the legs over the edge of the bed
Within 24 hours after surgery
Mobilization- Content
大体时间:Within 24 hours after surgery
Content of the mobilization performed i.e. which level of mobilization (sitting on the edge of the bed, standing by the bed, sitting in a chair and walking) which is reached.
Within 24 hours after surgery
Mobilization- Duration
大体时间:Within 24 hours after surgery
Duration of the mobilization performed, minutes
Within 24 hours after surgery
When any intervention with breathing exercises starts after surgery
大体时间:Within 24 hours after surgery
Time from termination of anesthesia to when the breathing exercise starts
Within 24 hours after surgery
Breathing exercise- Content
大体时间:Within 24 hours after surgery
Type of breathing exercise, as deep breathing, positive expiratory pressure or incentive spirometry.
Within 24 hours after surgery
Breathing exercise- Intensity
大体时间:Within 24 hours after surgery
Intensity of breathing exercise prescribed, sessions/time.
Within 24 hours after surgery

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)

2021年9月1日

初级完成 (实际的)

2022年2月28日

研究完成 (实际的)

2022年6月30日

研究注册日期

首次提交

2021年1月4日

首先提交符合 QC 标准的

2021年1月27日

首次发布 (实际的)

2021年1月28日

研究记录更新

最后更新发布 (实际的)

2022年8月16日

上次提交的符合 QC 标准的更新

2022年8月13日

最后验证

2022年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • FoU i VGR: 275327

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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