Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.
Minerva Anestesiol. 2013 Jul;79(7):741-9. Epub 2013 May 6.
Critically ill patients in Intensive Care Unit (ICU), due to their temporary or permanent incompetence, are often not capable to provide informed consent (IC), although required, for not emergency invasive procedures, like elective tracheostomy. By Italian law, a person with partially/temporarily physical/mental impairment needs a legal tutorship appointed by the court (Support Administrator, SA). We performed a national survey in Italy to investigate IC practice for elective tracheostomy procedure in critically ill conscious and unconscious patients in ICU.
Questions about IC were included in a survey concerning the clinical practice of tracheostomy in ICU. The survey was approved by the Italian Society of Anesthesia, Analgesia and Intensive Care (SIAARTI, n° 434 - 28 March 2012) and sent by e-mail to all members included in its mailing list. The duration of the survey was three months from April to June 2012. All required information was referred to the year 2011.
The mailed questionnaire correctly fulfilled was sent back by 131/427 (30%) national ICUs. Our data showed 1) in conscious patients, IC was obtained by 82.4% of ICUs; 2) in unconscious patients, IC was obtained in only 61.8% with different procedures not following the current Italian law, 3) for surgical tracheostomy performed in operating room, IC was obtained in conscious and unconscious patients in only 69.8% and 47.2% of ICUs, respectively, 4) risk/benefit informative document was provided in 61.1% ICUs, but available only in 47.2% of ICUs performing tracheostomy in operating room.
In Italian ICUs, participating to this study, the procedures related to IC for conscious and unconscious critically ill patients requiring surgical or percutaneous tracheostomy are not in line with current legal rules and procedures.
由于暂时或永久丧失能力，重症监护病房（ICU）中的危重病患者通常无法提供知情同意（IC），尽管需要对非紧急侵入性程序（如选择性气管切开术）进行知情同意，但这是有要求的。根据意大利法律，部分/暂时身体/精神障碍的人需要由法院任命的法定监护（支持管理员，SA）。我们在意大利进行了一项全国性调查，以调查 ICU 中意识清醒和无意识的危重病患者对选择性气管切开术的 IC 实践。
关于 IC 的问题被纳入一项关于 ICU 中气管切开术临床实践的调查中。该调查得到了意大利麻醉、镇痛和重症监护学会（SIAARTI，n°434-2012 年 3 月 28 日）的批准，并通过电子邮件发送给其邮件列表中包含的所有成员。调查的持续时间为 2012 年 4 月至 6 月的三个月。所有必需的信息均指 2011 年。
正确填写并寄回的问卷由 427 个国家重症监护病房中的 131 个回答。我们的数据显示：1）在意识清醒的患者中，82.4%的 ICU 获得了 IC；2）在无意识的患者中，只有 61.8%的 ICU 以不符合现行意大利法律的不同程序获得了 IC；3）对于在手术室进行的手术气管切开术，只有 69.8%和 47.2%的 ICU 在意识清醒和无意识的患者中获得了 IC；4）风险/受益信息文件在 61.1%的 ICU 中提供，但仅在 47.2%的在手术室进行气管切开术的 ICU 中提供。
在参与这项研究的意大利 ICU 中，与需要手术或经皮气管切开术的意识清醒和无意识的危重病患者的 IC 相关的程序不符合现行法律规定和程序。
