We Can’t Fix What We Don’t Know Awareness and Anaphylaxis incidents amongst the first 4,000 reports submitted to webAIRS Dr Martin Culwick Medical Director Dr Heather Reynolds Data Analyst The Australian and New Zealand Tripartite Anaesthetic Data Committee (ANZTADC); Department of Anaesthesia and Perioperative Medicine, Royal Brisbane & Women’s Hospital; The University of Queensland, Queensland, Australia

No conflicts of interest Aims Analysis of anaesthetic incidents using webAIRS What we do not know: What we think we know Awareness data Anaphylaxis data Fixing what we have found: Hierarchy of error reduction strategies The two steps of error reduction The Bowtie diagram to summarise the findings No conflicts of interest

Update

Incidents – Main Categories 750 per year – Tip of the iceberg

What do we already know? Internet searches Text books Journal articles Evidence Based Medicine Registries and big data

Text Book Example: Face Mask Ventilation Miller – Testing FMV before giving a muscle relaxant (1990) Kheterpal et al NAP 4 ANZCA Guideline

Awareness Potential Hazard No Harm or Near Miss Anaesthesia and Intensive Care Vol 45, 2017, Issue 4, p441-7 Awareness Potential Hazard No Harm or Near Miss

Awareness Awareness is postoperative recall of events during intended general anaesthesia, arising when anaesthetic delivery does not meet the patient’s context-specific anaesthetic requirement for amnesia for intraoperative events Awareness is unusual, occurring in only 0.1-0.2% of patients having general anaesthesia for surgery Awareness has the potential for a severe adverse impact on the patient’s experience Incident monitoring provides a view of the types of critical incidents associated with awareness, facilitating improvement of risk assessment

Reports of anaesthetic incidents were voluntarily submitted by clinicians to webAIRS from registered hospitals: a) A main category for the incident was selected from a pre-existing list b) A related subcategory was then selected from drop-down boxes c) The report included a narrative description of the incident, demographic patient information, details of the surgical procedure, type of anaesthesia and drugs administered Awareness

Awareness The database was searched using the following strategies to find incidents reporting “awareness” as the primary incident, or as a secondary consequence 1. Search terms were “neurological” as main category and “awareness/dreaming/nightmares” as subcategory 2. The narrative description was searched separately for the term “awareness” 3. Reports were reviewed as relevant from the context of the narrative, including incidents related to medication errors

Awareness Incidents were classified using an adaption of Bergman’s classification (2002): a) Awareness b) No awareness but increased risk of awareness c) No awareness and no increased risk of awareness

Results 61 incidents identified from search 16 incidents classified as “awareness” 4 (25%) → pEEG monitoring 15 (94%) → muscle relaxants 4 (25%) → propofol 12 (75%) → volatile anaesthesia maintenance 8 (50%) → signs of intraoperative wakefulness 6 (69%) → low anaesthetic delivery

Analysis of “awareness” incidents (n=16)

Analysis of 61 incidents

Issues involved Common clinical errors put patients at risk for “awareness” → Failure to check equipment Failure to turn on vaporisers Failure to maintain anaesthesia during difficult intubation and other crisis management situations Failure to monitor and adequately reverse neuromuscular blockade Mistakenly giving muscle relaxants to awake patients

Issues involved (continued) Electronic anaesthesia workstation errors with increased risk for patient “awareness” → Age-adjusted minimum alveolar concentration for previous patient was inadvertently used to guide anaesthetic delivery for the subsequent patient Volatile administration stopped because of failure to confirm a new target concentration on the workstation Failure to note that the target-controlled infusion device reset to zero when the alarm settings were changed

Interventions Rules, policies, education, news and publications Equipment Alarms - pEEG, Volatile %, MAC, Syringe driver etc And Cross Check Work process change - Stop – Preparing and labeling drugs Stop - Before giving a drug Stop - After induction Stop - After topping up a vapouriser or changing a TIVA syringe Stop - After or during a critical event Stop - Periodically during a case and then scanning the environment

Equipment Work process change Stop and Cross Check New policy Available and used Alarms – pEEG, Volatile %, MAC, Syringe driver etc (ensure activated) Work process change Stop and Cross Check New policy News & Publications Education and training

Awareness Bowtie Diagram

The webAIRS incident reporting system includes individual de-identified incidents with reports related to anaphylaxis during anaesthesia Anaphylaxis is an acute, severe, life-threatening allergic reaction in pre-sensitized individuals, leading to a systemic response caused by the release of immune and inflammatory mediators from basophils and mast cells Anaphylaxis

At least 2 organ systems are involved, such as the skin, the upper and lower airways, the cardiovascular, neurologic, and GI systems, in this order of priority or in combination. Allergy to medications is a frequent cause. Similar symptoms caused by nonimmunologic mechanisms are termed anaphylactoid reactions. Anaphylaxis

Anaphylaxis Key diagnostic factors hypotension bronchospasm urticaria angioedema flushing Treatment ABC approach early administration of adrenaline

Anaphylaxis – 205 cases in first 4000

What can we do to improve outcomes from anaphylaxis? Prevention – difficult except by checklist for prior episode Management System factors Anaphylaxis Kit Human factors Checklists and Diagnostic Card Training, simulation and emergency response wokshops Education

WebAIRS Data - diagnosis CVS 720 18% Resp 1172 29% Anaphylaxis 205 Reports First 4000 Reports System Clinical Signs Count Percent First Sign CVS Conscious Level 15 7.3% 2 1.0% 720 18% Arrythmia 12 5.9% Bradycardia 13 6.3% 1 0.5% Tachycardia 81 39.5% 25 12.2% Cardiac Arrest 41 20.0% 7 3.4% Hypotension 179 87.3% 77 37.6% Resp Airway Oedema 1172 29% Bronchospasm 54 26.3% 10 4.9% Cough 9 4.4% CO2 32 15.6% 8 3.9% Desaturation 59 28.8% 6 2.9% High Ventilation Pressure 63 30.7% 26 12.7% Other 30 14.6% Skin Angioedema (Skin) 22 10.7%   Rash 124 60.5% 19 9.3% Disclaimer: Results displayed are preliminary and require confirmation Downloaded on 9th May 2017 from http://anzaag.com/Docs/PDF/Management%20Guidelines/Diagnostic%20card%20v1.1Jun13.pd f

Additional Disclaimer: Results displayed are preliminary and require confirmation

Disclaimer: Results displayed are preliminary and require confirmation Cardiovascular System Adrenaline Infusion Noradrenaline Infusion Metaraminol infusion Phenylephrine Infusion Glucagon Vasopressin ECMO or CPB DCCV Yes 121 28 7 17 1 10 5 8 Percent 59.0% 13.7% 3.4% 8.3% 0.5% 4.9% 2.4% 3.9% Respiratory Salbutamol Inhalational Salbutamol IV Magnesium Aminophylline Inhalational Anaes. Agents Ketamine Yes Percent 18 12 8 3 7 8.8% 5.9% 3.9% 1.5% 3.4% Downloaded on 9th May 2017 from http://anzaag.com/Docs/PDF/Management%20Guidelines/Diagnostic%20card%20v1.1Jun13.pd f Disclaimer: Results displayed are preliminary and require confirmation

Anaphylaxis – Bowtie Diagram

Two Steps To Making Effective Changes More complex, more expensive, and take longer to implement but potentially much more effective Work process change Checklists Recommendations News & Publications Education and training Step 1 Easy Low Cost Important N.B. The information is not usually available at point of care in a format where it is practical to use We already have these interventions in place

Summary Analysis of anaesthetic incidents using webAIRS What we do not know What we think we know Awareness data Anaphylaxis data Fixing what we have found Hierarchy of error reduction strategies Two steps to effective changes The Bowtie Diagram to summarise the findings

Conclusion Build a safety culture Promote anaesthetic incident recording Implement safety solutions to prevent harm Always look for two steps to reduce errors 1. Quick and easier to implement 2. More complex and expensive but more effective

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