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Vargas M. 1, 2, Servillo G. 2, Antonelli M. 3, Brunetti I. 1, De Stefano F. 4, Putensen C. 5, Pelosi P. 1
1 Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy;
2 Department of Anesthesia and Intensive Care Medicine, University of Naples, Naples, Italy;
3 Department of Intensive Care and Anesthesiology, Università Cattolica del Sacro Cuore, Rome, Italy;
4 Department of Health Sciences, University of Genoa, Italy;
5 Department of Anesthesiology and Intensive Care Medicine, University of Bonn, Bonn, Germany
Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.