1
Q
Define “critical incident”
A
Any event which results in actual harm or would do so if not actively managed.
2
Q
Which organisation is responsible for co-ordinating national reporting of critical incidents and disseminating info learned?
A
National Patient Safety Agency
3
Q
What are the stages of critical incident reporting? (7)
A
- Notification (via Trust intranet to risk management dept)
- Investigation
- Analysis
- Conclusions
- Implementation of action
- Feedback to staff (MM meeting)
- Monitoring of actions
4
Q
What info should be given to patient taking part in clinical trial?
A
- Study title and invitation
- Reason for trial
- Details of patient involvement
- Explanation of randomisation, risks & benfits
- Assurance of confidentiality
- Ability to refuse / withdraw
- Involvement of other parties (eg pharma company)
- Subject’s GP informed
- Researcher’s name and contact details
- Any conflict of interest (commercial, political)
5
Q
Clinical Trial: Design Features (7 steps)
A
- Subject selection:
- Groups should be matched (age, sex, ASA)
- Inclusion / exclusion criteria defined
- Selection bias to be avoided - Sample size
- Must be appropriate to avoid Type 1 and Type 2 errors
- Power = ability to reveal a difference of a particular size; should be calculated before study commences. - Randomisation and blinding
- by computer-generated program (reduces bias) - Data collection
- Guidelines drawn up
- small number of appropriately trained collectors
- machinery / monitors tested and calibrated - Statistical evaluation
- Establish type of data and apply appropriate tests - Endpoint
- Determined either by total number studied or periodic analysis of results - Publication / Interpretation
- comprehensive account of methods
- raw data available for analysis
- statistical significance does not equal clinical significance
6
Q
EBM: Grades of Evidence
A
I - High quality meta-analysis or systematic review of RCTs
II - RCTs
III - Experimental studies without randomisation
IV - Well designed non-experimental studies
V - Expert opinion / case reports
7
Q
EBM: Recommendations
A
A - Consistent level I studies
B - Consistent level II/III studies
C - IV evidence or extrapolation from II/III
D - V / inconclusive or inconsistent studies
8
Q
EBM: Phases of pharmacological clinical trials
A
Pre-clinical studies: in-vivo
Phase 0 - Human micro dosing - sub-therapeutic dose to 10-15 subjects
Phase I - Small group (20-50) healthy volunteers. Assess safety, tolerability, PK & PD.
Phase II - 200-300 patients
Phase III - Multicentre RCTs to define efficacy
Phase IV - Post marketing surveillance trials to detect rare / long-term adverse effects.
9
Q
Define “systematic review” and “meta-analysis”
A
Systematic review - a method to confirm or refute an effect from a number of RCTs that individually may have been too small to demonstrate.
Meta-analysis: the statistical tool that aggregates this data
10
Q
What is the Methodology of a systematic review and meta-analysis? (7)
A
- Pose a question
- Define trial inclusion criteria
- Systematic search for studies - may include abstracts and unpublished studies
- Authors may need to be contacted for raw data
- Studies are individually weighted for size (ie power) and quality
- Results displayed as Forest plot (x axis: trials, y axis: odds ratio)
- Odds ratio (95% CI) crossing 1 indicates no statistical significance.
11
Q
Advantages of meta-analysis (2)
A
- Can produce consensus on a number of trials with contradictory findings.
- May result in higher statistical significance where none existed individually
12
Q
Disadvantages of meta-analysis (6)
A
- Credibility damaged if included RCTs are based on different populations
- Flaws in methodology may be carried from individual studies to systematic review
- Searching may be subject to publication bias (funnel plot used to uncover this)
- Double counting may occur (same data published in multiple papers)
- Coding and decision to include study is subjective
- Potential COI (no ethical approval needed)
13
Q
Consent requires (3): (AAGBI 2006)
A
- Patient to have capacity to understand and remember relevant info and options
- Full disclosure of relevant info
- Autonomy to make voluntary decision even if it seems irrational
14
Q
Legal considerations re consent (5):
AAGBI 2006
A
- Performing procedure without consent may be interpreted as battery
- Inadequate counselling when obtaining consent may result in charge of negligence
- Treating Dr is responsible for ensuring patient is consented
- Significant risks should be discussed in accordance with Bolam principle
- Refusal of treatment in a competent adult is legally binding, even if it results in death
15
Q
Process of consent (6):
AAGBI 2006
A
- May be written, verbal, implied or expressed
- Info provided: procedure, indications, risks - common and rare but serious
- Patients given opportunity to ask questions; honest answers provided
- Formal signed consent not required but recommended for invasive procedures or those with significant risk (e.g. CVP lines)
- Documentation is paramount where no formal writted consent (e.g. conversion to GA in LSCS)
- Qualified consent: where patient reuses certain aspects of treatment (e.g. Jehovah’s witness)
16
Q
Define “clinical risk”
A
The potential of for an unwanted outcome
17
Q
5 stages of clinical risk management
A
- Awareness - that complexity of healthcare has inherent risks
- Identification (prospective / retrospective)
- Assessment - of risk magnitude
- Management - plans / strategies to minimise risk
- Re-evaluation - continuous process of review
18
Q
Sources of risk to anaesthetized patients (4)
A
- Actions/inactions of anaesthetist
- Actions/inactions of surgeon
- Failure/malfunction of equipment
- Organisational risks
19
Q
Ways to reduce risk to patients: Anaesthetist / Surgeon related (8):
A
- Training:
- competency-based training
- Formal exam-based assessments
- Appropriate supervision of trainees - Simulators / training devices
- Training to deal with rare life-threatening emergencies - Continuing medical education
- Avoidance of fatigue
- EWTD for doctors’ hours - Vigilance re drug/alcohol abuse
- Anaesthetic / surgical planning
- Checklists / guidelines and protocols
- Minimum monitoring standards (AAGBI)
- Throat packs - Critical incident / SUI reporting
- All Trusts submit data to NPSA; allowing publication of ‘Patient Safety Alerts’
- Highlights areas of danger (e.g. similar plastic vials of potassium and saline)
20
Q
Ways to reduce risk to patients: Theatre related (3):
A
- WHO surgical checklist
- 3 phased checklist
- ‘Sign in’ prior to induction to identify anaesthetic risk
- ‘Time out’ prior to incision; confirms consent, surgeons concerns, abx, DVT prophylaxis
- ‘Sign out’ before patient leaves OR; includes count of surgical instruments and concerns for recovery - Standardisation of hospital wristbands
- Marking of surgical site at same time as consenting patient before leaving ward
21
Q
Ways to reduce risk to patients: Anaesthetic equipment related (3):
A
- Regular equipment checks - by anaesthetists, ODPs
- Protocols: course of action if equipment fails
- Development of equipment to reduce risks: pre-filled epidural mixtures; catheters with unique syringe connectors to avoid inadvertent iv administration of LA
22
Q
Ways to reduce risk to patients: Organisation related:
A
- Endure high quality employment practice (locum procedures; reviews of individual and team performance)
- Provision of safe environment (estates, privacy)
- Well designed policies on public envolvement
- Regular audit and governance meetings
23
Q
7 Pillars of Clinical Governance
A
P atient and public involvement I nformation and IT R isk management A udit T raining and education E ffectiveness in clinical care S taff Management
24
Q
Malnutrition: definition (3)
A
- BMI <18.5
- Unintentional weightloss >10% in 3-6m
- BMI <20 with unintentional weightloss >5% in 3-6m
25
Malnutrition: risk factors (5)
1. Elderly
2. Alcoholism
3. Chronic illness
4. GIT surgery / disease
5. Mental illness (incl. anorexia)
26
Malnutrition: implications (8)
1. Decreased wound healing
2. Weakness (incl respiratory muscles)
3. Anaemia
4. Immunological compromise
5. Hypoproteinaemia
6. Dehydration
7. Electrolyte disturbance
8. Hypothermia
27
Malnutrition: identifying patients (3)
| NICE 2006
1. Screen BMI on admission
2. Consider nutritional support for those at risk
3. Specialist nutrition nurse in all Trusts
28
Malnutrition: Aneas implications
1. Take thorough history: drug/alcohol/eating habits
2. FBC, UandEs, LFTs, Phos, Mg2+, Ca2+, glucose - correct abnormalities
3. ECG (arrhythmia risk: long QT, AV block, ST depression)
4. Careful positioning - avoid tissue / nerve damage)
5. Monitor temp; avoid hypothermia
6. Altered drug metabolism
- Prolonged block from NDMRs if electrolyte abN
- Increased 'free drug' due to decreased drug binding if low alb.
- Metabolism / clearance affected by ↑↓BMR
29
Alcohol intoxication:
1. Annual cost to NHS
2. DD (3)
3. Complications (4)
(CEACCP 2009)
1. £3bn
2. HI, coma, drug OD
3. Confusion, agitation, psychomotor impairment, inability to give informed consent
30
Chronic alcohol abuse: CVS effects (4)
Cardiomyopathy
Heart failure
HTN
Arrhythmias
31
Chronic alcohol abuse: CNS effects (3)
Wernicke-Korsakoff
Peripheral neuropathy
Autonomic dysfunction
32
Chronic alcohol abuse: GI effects
ALD
Pancreatitis
Gastritis
Oesoph / bowel CA
33
Chronic alcohol abuse: Metabolic effects
```
Hyperlipidaemia
Obesity
Hypoglycaemia
Low K+
Low Mg++
High urea
```
34
Chronic alcohol abuse: Heamatological effects
Macrocytosis
Low plts
Leucopoenia
35
Chronic alcohol abuse: MSK effects
Myopathy
Osteoporosis
Osteomalacia
36
COPD is characterised by:
1. Chronic bronchitis (cough with productive sputum for at least 3/12 on 2 consecutive years)
2. Emphysema (permanent destructive enlargement of airspaces distal to the terminal bronchioles without obvious fibrosis)
37
Causes of COPD (3)
Smoking
Occupational exposure
Genetic causes
38
Smoking: Acute effects (3)
1. Nicotine stimulation of SNS: tachycardia and HTN
2. Decreased O2 delivery due to COHb
3. Resulting in increased cardiac workload
39
Smoking: Chronic RS effects (3)
1. COPD: due to increased proteases and decreased anti-proteases such as a1-antitrypsin
2. Increased airway resistance and reactivity
3. Increased post op respiratory complications
40
Smoking: Chronic CVS effects (3)
IHD
PVD
Decreased wound healing and graft success
41
Smoking: Chronic CNS effects
Addiction
| Increased risk of aneurism rupture
42
Benefit of peri-op smoking cessation (4)
12-24h: decreased COHb and nicotine
48-72h: Increased sputum production
2/52: decreased sputum, increased airway reactivity (bronchoconstriction, laryngospasm)
8/52: ↓post-op RS complications
43
Smoking: Pre-op measures (4 headings)
1. History:
- pack-years
- Ex tol, dyspnoea, cough, sputum
- ?IHD, HTN
- Meds
- Hospital / ITU admissions
2. Examination
- Dyspnoea, resp pattern
- Heart failure, PVD
3. Investigations
- Bloods: FBC - ↑WCC, polycythaemia
- ABG: hypoxia, CO2 retention
- CXR - emphysema, bullae, malignancy
- ECG: ?ischaemia/ infarct, ventricular strain
- PFTs: Predictors of post-op ventilation:
i) FEV1<1L
ii) FEV2/FVC <50%
iii) PaCO2 >7kPa
4. Pre-op optimisation:
- Cessation ideally 2/12 before surgery
- Physiotherapy
- Optimise meds
- Treat infections
- Consider CPEX if major surgery
44
Smoking: Intra-op risks and measures (5)
1. RA where poss (↓ intubation / vent and ↓post-op resp complications
2. ↑ coughing, laryngospasm and desaturation on induction and emergence.
3. Histamine-releasing drugs (atracurium) ↑ risk of bronchospasm
4. Large doses of opioids may impair resp function in CO2 retaining patients
5. Spontaneous ventilation may be difficult (airway irritability)
- consider NDMR and IPPV
- pneumothorax more common with bullae, N2O
45
Smoking: Post-op (5)
1. Extubate and recover sitting up (beware CO2 retainers and prolonged high flow O2)
2. Elective HDU/ITU if severe COPD
3. Adequate analgesia ↓ post-op respiratory complications
4. Early physio and ambulation
5. Regular bronchodilators until fully mobile
46
Drug abuse: anaes considerations (5)
1. High index of suspicion in all patients req emergency / trauma surgery
2. Alcohol abuse + complications may co-exist
3. CNS depressants may complicate pt presenting with ↓GCS
4. Stimulants (amph, cocaine) may cause hallucinations, psychoses, tachycardia, increased volatile/ induction requirements
5. Consider chronic effects: hepatic impairment, enzyme induction, cardiomyopathy
47
IV drug abuse: complications (5)
1. Sepsis
2. Thrombophlebitis
3. endocarditis
4. Difficult iv access
5. Difficult post-op pain control - discuss management pre-operatively (e.g. RA)
48
Drug abuse: Peri-op management (5)
1. Early involvement of drug-dependency team
2. Full infective precautions
3. Consider ↑↓ requirements for analgesia / anaesthesia
4. RA where possible
5. Acute pain team involvement
49
Crack / Cocaine considerations (6)
1. Adrenergic-receptor stimulant derived from Erythroxylon coca plant
2. May precipitate widespread vasospasm → arrhythmias, Ao dissection, IHD, coronary a. spasm, intracerebral events, sudden death
3. Inhalation may → pulm oedema and haemorrhage
4. Intra-arterial injection may → limb / organ ischaemia
5. Pre-op: consider stabilisation on ITU with vasodilators, anti-HTN, anti-arrhythmics
6. Peri-op: invasive monitoring, avoid vasopressors if poss.
50
Hepatitis: Definition + causes (4)
Def: Inflammn of liver from any cause
Causes:
1. Infective: viral (A,B,C,D,E), bacterial (leptospirosis), protozoal (toxoplasmosis)
2. Drug-induced: idiosyncratic (MAOIs), dose-related (alcohol)
3. Metabolic: Wilson's, pregnancy
4. CV: RH failure, severe HTN
51
Hep B: Cause
DNA virus
| Vertical transmission, blood, body secretions
52
Hep B: Symptoms (5)
```
Fever
GIT symptoms
raised LFTs
hepatomegaly
jaundice
```
53
Hep B: Prevention
1. Active immunisation (anti-HBs) of high risk groups
2. Passive immunisation 0-7 days after exposure (Ig)
3. Screening of blood for transfusion
4. Universal precautions
54
Sequelae of carrier state Hep B and C
Hep B: hepatic failure, hepatocellular CA
Hep C: Cirrhosis (20-30y post-exposure), hepatocellular CA
55
HIV: 20% of all HIV patients will have anaesthetic - commonly for (4):
Lymph node biopsies
Splenectomies
Parital colectomies
CVP line insertion
56
HIV pathophysiology (4)
1. Retroviral lentivirus
2. Contains reverse transcriptase viral RNA→DNA in corporated into host genome)
3. Infects + destroys CD4+ T-Lymphocytes
4. Reduces host immunity
57
HIV stages of disease
I - Acute seroconversion (asymptomatic with high viral load)
II - Asymptomatic infection (median time to AIDS = 10y)
III - Persistant generalised lymphadenopathy
IV - Symptomatic HIV infection
58
HIV detection
anti-HIV IgG via ELISA
| HIV RNA detection
59
HIV treatment
1. Nucleoside reverse transcriptase inhibitors (NRTIs) e.g. Zidovudine
2. Non-nucleoside reverse transcriptase inhibitors (NNRTIs) e.g. Nevirapine
3. Protease inhibitors (PIs) e.g. Saquinavir
Note: poor compliance due to SEs and complicated regimes
60
Pre-op assessment of patient with AIDS: RS (5)
1. Opportunistic infections:
- Fungal (PCP, aspergillosis, candidiasis)
- Bacterial (TB, atypical mycobacter, strep, staph)
- Viral (CMV, hepetic)
2. Cavitating lung disease (TB, abscess)
3. Kaposi's sarcoma, lymphoma
4. ABGs, spirometry
5. Consider post-op ITU
61
Pre-op assessment of patient with AIDS: CVS (4)
1. Opportunistic infection (endocarditis, esp if IVDU)
2. Myocarditis + dilated cardiomyopathy
3. Arrhythmias (secondary to brainstem infection)
4. ECG + echo
62
Pre-op assessment of patient with AIDS: GIT (3)
1. D+V
2. Anorexia
3. Check + correct electrolytes
63
Pre-op assessment of patient with AIDS: CNS (5)
1. Opportunistic infections: Cryptococcus, mycobacter
2. Encephalitis (HSV) + meningitis
3. Neoplasia
4. Polyneuropathy
5. HIV-related dementia
64
Pre-op assessment of patient with AIDS: Haem (4)
1. ↓Hb, ↓plts, ↓WCC
2. Additional steroids may be needed for those treated for peripheral neuropathy
3. IVDUs - poor access
4. Drug interactions
65
Pre-op assessment of patient with AIDS: Obstetrics (3)
Vertical transmission (~25%) reduced by:
- Antiretrovirals at delivery
- Elective LSCS
- Abstaining form Br feeding (risk 10-20%)
66
HIV: risk to anaesthetist (2)
1. Needlestick injury - 0.3%
| 2. Mucocutaneous transmission - 0.03%
67
HIV transmission: risk reduction (4)
1. Universal precautions
2. Gloves reduce transmission by 10-100x
3. Disposable equipment
4. Post-exposure prophylaxis (ideally within 1-2h)
68
Prion disease: Pathophysiology (5)
1. Small proteinaceous particles
2. Cause Bovine Spongiform Encephalitis (BSE) and variant Creuzfeldt-Jakob Disease (vCJD) in humans.
3. Progressive neurological symptoms + death occur within months
4. Highest concentration of prion protein: brain, spinal cord, posterior eye
5. Also detected post-mortem in: appendix, tonsils, spleen, GI lymph nodes
69
Prion disease: prevention of transmission (4)
1. Prions are resistant to deactivation by most sterilisation procedures
2. Currently no reliable method to sterilise equipment
3. Washing may reduce prion conc exponentially: 10-20 cycles may render infections risk to negligible
4. Fibre-optic endoscopes:
- Cannot be autoclaved
- Glutaraldehyde disinfection has no effect on prions
- Sodium hydroxide would need damaging concentrations
70
Prion Disease: Anaesthetic management of suspected CJD (4)
1. High risk procedures: tonsillectomy + adenoidectomy
2. High index of suspicion
i) Clinical features suggestive of CJD
ii) Recipients of hoemones derived from human pituitary glands or human dura mater grafts
3. Universal precautions, full aseptic techniques
4. Single-use disposable instruments especially laryngoscope blades
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