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NATIONAL AUDIT INTO THE SAFETY OF DEEP SEDATION
14
INTRODUCTION
Sedation provided by anaesthesiologists has been shown significantly to reduce sedation
related complications compared with non-anaesthesiologist administered sedation.
1
However, the growing demand for procedural sedation and analgesia (PSA) stretches the
service provision of anaesthesiologists. In order to accommodate the growing demand for
procedural sedation a special sedation practitioner (SP) training programme for certified
anaesthetic nurses has been developed in the Netherlands. Since 2007 moderate to deep
PSA has been provided by SPs for a wide range of patients (ASA I to ASA IV classifications)
and procedures - under indirect supervision of an anaesthesiologist. However, no data
exists regarding the safety and efficacy of this practice.
Definitions for sedation related adverse events (AEs) vary widely in the literature with
reported AE incidence rates of 0.65% to 49%.
2-6
The International Sedation Task Force
(ISTF) of the World Society of Intravenous Anaesthesia (SIVA) therefore created a tool to
standardise the definitions of sedation related AEs.
7
The aim of this study was to report the incidence and management of sedation-related
AEs during PSA performed by SPs in the Netherlands using the World SIVA adverse event
reporting tool.
7
Our hypothesis was that SPs are able to guarantee safe sedation practice
with a complication rate of serious events of < 0.1%.
METHOD
This prospective observational data registry includes consecutive cases of adult patients
undergoing PSA in 24 Dutch hospitals from the 1st February 2015 to 1st March 2016.
In order to make this study feasible, data was collected in an anonymous fashion. The
requirement for informed consent was waived by the Medical Ethics Committee of the
Academic Medical Centre, Amsterdam (W15_031#15.0040).
Setting of the study
The SP curriculum is a part-time programme consisting of a total of 1264 hours. In order to
be eligible to enter the training programme, experience as a certified anaesthesia nurse or
anaesthesia physician assistant is required.
In the Netherlands, anaesthesia nurses have completed a 3-year fulltime training
programme; they are trained in advanced life support, have advanced airway skills, and are
allowed to give certain drugs to the patient during anaesthesia under indirect supervision
of an anaesthesiologist.
A certified SP is allowed toperformPSAownhis own responsibility under indirect supervision
of an anaesthesiologist.
8
PSA is usually provided outside of the operating theatre in the
endoscopy or radiology department. The supervising anaesthesiologist must therefore