Presented by Mark Roback, MD
Attendees at the 2018 SPS Annual Conference were treated to an insightful plenary session considering meaningful outcomes in procedural sedation entitled “Sedation Outcomes: Definitions and Assessment Tools” presented by Mark Roback, MD, Co-Director of the Division of Emergency Medicine at University of Minnesota Masonic Children’s Hospital. With an emphasis on sedation safety and efficacy drawn from the Institute of Medicine’s Six Aims of Quality and the 2011 Multidisciplinary Consensus Conference on Quality in Pediatric Sedation, Dr. Roback highlighted the imperative to define, track, and refine procedural sedation performance and benchmarks. He presented current challenges to this important undertaking and advocated for a construct to standardize definitions and a tracking tool applicable to procedural sedation in non-operating room settings by the spectrum of sedation provider disciplines.
The monitoring of sedation adverse events and outcomes has long been a requirement, but variability in definitions, in methods of collection and reporting, in sedation contexts, and in grading of importance, all pose challenges to interpretation and comparison of reported data. With respect to sedation safety, historical approaches to defining adverse events have been threshold/duration-focused (e.g., Oxygen Desaturation = pulse oximetry <93% for >30 seconds), but, as Dr. Roback presented, apart from assigning event occurrence, an understanding of clinical relevance is lacking from such a definition strategy. Instead of mere event occurrence, Dr. Roback presented the construct of intervention-based event definition introduced in the “Quebec Guidelines” from a 2009 Annals of Emergency Medicine publication intended to standardize terminology based on clinical intervention. In this paradigm, no threshold or duration is required but an event prompting one or more interventions to rectify is reportable, and when coupled with further documentation of objective characteristics surrounding the event, the clinical significance of the event may be derived (e.g., Oxygen Desaturation = pulse oximetry <93% AND vigorous tactile stimulation + airway repositioning resulting in restoration of normal oxygenation is distinct in magnitude from pulse oximetry <93% AND vigorous tactile stimulation + airway repositioning + placement of an oral airway + bag-valve mask ventilation to restore normal pulse oximetry measurement.). In the paradigm Dr. Roback proposed, a sedation-related adverse event is an unexpected and undesirable response to medication(s) and medical interventions used to facilitate procedural sedation and analgesia that threatens or causes harm or discomfort to the patient.
To assess fully the sedation experience, Dr. Roback asserted that procedural completion alone is insufficient, and that patient safety, while the ultimate priority, is not synonymous with sedation efficacy. The “Quebec Guidelines” emphasize sedation efficacy in terms of safe facilitation of procedural completion without physical restraint through pharmacologic attenuation of pain, anxiety, and movement such that the patient did not experience adverse events resulting in abandonment of the procedure, permanent complication, unplanned admission to the hospital, prolonged sedation recovery, or unpleasant recall of the procedure. Furthermore, the Pediatric Sedation State Scale is a validated tool recently published in Pediatrics in 2017 that assesses effectiveness of a respective sedation strategy—be that pharmacologic, behavioral, technological, or some combination thereof—in facilitating conditions necessary to complete a respective procedure in line with patient physiologic parameters.
Having established the priorities of useful conceptions of definitions pertaining to safety and efficacy, Dr. Roback briefly reviewed a sedation-related adverse event tool formulated by the International Sedation Task Force of the World Society for Intravenous Anaesthesia (SIVA) published in the British Journal of Anaesthesia in 2012. This tool utilizes a combination of both threshold/duration and intervention-based definitions, involves a multi-step process, is not organized by organ system, and prioritizes events while under-emphasizing outcomes. However, the World SIVA approach’s contribution to robust quality/safety assurance is its categorization of events according to increasing levels of severity with accompanying recommendations for reporting and immediacy of review.
The crux of Dr. Roback’s presentation was introducing a new tool for sedation safety and efficacy monitoring devised through a multi-step, sequential consensus generation process, which Dr. Roback spearheaded for the International Committee for the Advancement of Procedural Sedation (ICAPS), a multidisciplinary, international, independent consensus committee featuring 20 prominent sedation researchers representing nine countries spanning six continents. Termed TROOPS (Tracking & Reporting Outcomes Of Procedural Sedation), this tool offers a standardized template intended for daily use by sedationists caring for patients of all ages in locations outside the operating room to document sedation-related adverse events, interventions performed, efficacy and outcomes. Collated by organ systems (airway/breathing, circulation, neurologic), specific events are classified in terms of severity: INTERMEDIATE items (e.g., positive pressure ventilation, placement of oral airway) can endanger patients if not promptly managed and warrant timely reporting with peer scrutiny; SENTINEL items (e.g., tracheal intubation, chest compressions) are life-threatening and warrant immediate reporting and the highest level of peer scrutiny. The template includes a section with options for Suspected Etiology to the respective events and features a Sedation Quality & Patient Experience section in which insufficiency of sedation, need for escalation of care, and dissatisfaction of either provider or patient/family may be recorded. Dr. Roback et al have published TROOPS in the British Journal of Anaesthesia this year. Work is currently underway to allow TROOPS to interface with electronic medical records, yielding a user-friendly tool that does not require a significant time investment or redundancy in documentation.
Click HERE for further information about TROOPS.
Dr. Roback presented a logical approach to the consideration of the quality aspects of safety and efficacy, which the Society for Pediatric Sedation has championed since its inception. His introduction of a readily navigable, provider-considerate tool offers research- and quality-minded sedationists and services an option that will enhance tracking and reporting moving forward. Recognizing the breadth of sedation practice, the SPS will benefit from the work of Dr. Roback who further encouraged establishing and maintaining a high-bar for safety and efficacy in the procedural sedation care of our patients.