Institute of Health and Caring Sciences, The Sahlgrenska Academy, University of Gothenburg, Sweden.
Faculty of Caring Science, Work Life and Social Welfare, Borås University College, Sweden.
Aust Crit Care. 2018 Mar;31(2):59-70. doi: 10.1016/j.aucc.2017.04.001. Epub 2017 May 12.
Currently, it is well known that the sound environment in intensive care units (ICU) is substandard. Therefore, there is a need of interventions investigating possible improvements. Unfortunately, there are many challenges to consider in the design and performance of clinical intervention studies including sound measurements and clinical outcomes.
(1) explore whether it is possible to implement a full-scale intervention study in the ICU concerning sound levels and their impact on the development of ICU delirium; (2) discuss methodological challenges and solutions for the forthcoming study; (3) conduct an analysis of the presence of ICU delirium in the study group; and (4) describe the sound pattern in the intervention rooms.
A quasi-randomized clinical trial design was chosen. The intervention consisted of a refurbished two-bed ICU patient room (experimental) with a new suspended wall-to-wall ceiling and a low frequency absorber. An identical two-bed room (control) remained unchanged.
Patients >18 years old with ICU lengths of stay (LoS) >48h. The final study group consisted of 31 patients: six from the rebuilt experimental room and 25 from the control room. Methodological problems and possible solutions were continuously identified and documented.
Undertaking a full-scale intervention study with continuous measurements of acoustic data in an ICU is possible. However, this feasibility study demonstrated some aspects to consider before start. The randomization process and the sound measurement procedure must be developed. Furthermore, proper education and training are needed for determining ICU delirium.
This study raises a number of points that may be helpful for future complex interventions in an ICU. For a full-scale study to be completed a continuously updated cost calculation is necessary. Furthermore, representatives from the clinic need to be involved in all stages during the project.
目前，众所周知，重症监护病房（ICU）的声音环境不达标。因此，需要进行干预研究，以探索可能的改善措施。不幸的是，在设计和进行临床干预研究时，包括声音测量和临床结果，需要考虑许多挑战。
（1）探讨在 ICU 内进行全面的声音水平干预研究及其对 ICU 意识障碍发展的影响是否可行；（2）讨论即将进行的研究的方法学挑战和解决方案；（3）对研究组中 ICU 意识障碍的存在进行分析；（4）描述干预病房的声音模式。
选择了一种准随机临床试验设计。干预措施包括对一间两床 ICU 病房（实验组）进行翻新，安装新的悬挂式墙壁到天花板和低频吸声器。一间相同的两床病房（对照组）保持不变。
年龄>18 岁，入住 ICU 时间>48 小时。最终的研究组包括 31 名患者：六名来自重建的实验病房，25 名来自对照病房。不断识别和记录方法学问题和可能的解决方案。
在 ICU 中进行全面的干预研究并对声学数据进行连续测量是可行的。然而，这项可行性研究表明，在开始之前需要考虑一些方面。必须制定随机化过程和声音测量程序。此外，需要对确定 ICU 意识障碍进行适当的教育和培训。
本研究提出了一些在 ICU 进行复杂干预时可能有帮助的要点。为了完成全面的研究，需要进行持续更新的成本计算。此外，临床代表需要在项目的所有阶段都参与。
