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Define "critical incident"

Any event which results in actual harm or would do so if not actively managed.


Which organisation is responsible for co-ordinating national reporting of critical incidents and disseminating info learned?

National Patient Safety Agency


What are the stages of critical incident reporting? (7)

1. Notification (via Trust intranet to risk management dept)
2. Investigation
3. Analysis
4. Conclusions
5. Implementation of action
6. Feedback to staff (MM meeting)
7. Monitoring of actions


What info should be given to patient taking part in clinical trial?

1. Study title and invitation
2. Reason for trial
3. Details of patient involvement
4. Explanation of randomisation, risks & benfits
5. Assurance of confidentiality
6. Ability to refuse / withdraw
7. Involvement of other parties (eg pharma company)
8. Subject's GP informed
9. Researcher's name and contact details
10. Any conflict of interest (commercial, political)


Clinical Trial: Design Features (7 steps)

1. Subject selection:
- Groups should be matched (age, sex, ASA)
- Inclusion / exclusion criteria defined
- Selection bias to be avoided

2. 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.

3. Randomisation and blinding
- by computer-generated program (reduces bias)

4. Data collection
- Guidelines drawn up
- small number of appropriately trained collectors
- machinery / monitors tested and calibrated

5. Statistical evaluation
- Establish type of data and apply appropriate tests

6. Endpoint
- Determined either by total number studied or periodic analysis of results

7. Publication / Interpretation
- comprehensive account of methods
- raw data available for analysis
- statistical significance does not equal clinical significance


EBM: Grades of Evidence

I - High quality meta-analysis or systematic review of RCTs
III - Experimental studies without randomisation
IV - Well designed non-experimental studies
V - Expert opinion / case reports


EBM: Recommendations

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


EBM: Phases of pharmacological clinical trials

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.


Define "systematic review" and "meta-analysis"

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


What is the Methodology of a systematic review and meta-analysis? (7)

1. Pose a question
2. Define trial inclusion criteria
3. Systematic search for studies - may include abstracts and unpublished studies
4. Authors may need to be contacted for raw data
5. Studies are individually weighted for size (ie power) and quality
6. Results displayed as Forest plot (x axis: trials, y axis: odds ratio)
7. Odds ratio (95% CI) crossing 1 indicates no statistical significance.


Advantages of meta-analysis (2)

1. Can produce consensus on a number of trials with contradictory findings.
2. May result in higher statistical significance where none existed individually


Disadvantages of meta-analysis (6)

1. Credibility damaged if included RCTs are based on different populations
2. Flaws in methodology may be carried from individual studies to systematic review
3. Searching may be subject to publication bias (funnel plot used to uncover this)
4. Double counting may occur (same data published in multiple papers)
5. Coding and decision to include study is subjective
6. Potential COI (no ethical approval needed)


Consent requires (3):
(AAGBI 2006)

1. Patient to have capacity to understand and remember relevant info and options
2. Full disclosure of relevant info
3. Autonomy to make voluntary decision even if it seems irrational


Legal considerations re consent (5):
(AAGBI 2006)

1. Performing procedure without consent may be interpreted as battery
2. Inadequate counselling when obtaining consent may result in charge of negligence
3. Treating Dr is responsible for ensuring patient is consented
4. Significant risks should be discussed in accordance with Bolam principle
5. Refusal of treatment in a competent adult is legally binding, even if it results in death


Process of consent (6):
(AAGBI 2006)

1. May be written, verbal, implied or expressed
2. Info provided: procedure, indications, risks - common and rare but serious
3. Patients given opportunity to ask questions; honest answers provided
4. Formal signed consent not required but recommended for invasive procedures or those with significant risk (e.g. CVP lines)
5. Documentation is paramount where no formal writted consent (e.g. conversion to GA in LSCS)
6. Qualified consent: where patient reuses certain aspects of treatment (e.g. Jehovah's witness)


Define "clinical risk"

The potential of for an unwanted outcome


5 stages of clinical risk management

1. Awareness - that complexity of healthcare has inherent risks
2. Identification (prospective / retrospective)
3. Assessment - of risk magnitude
4. Management - plans / strategies to minimise risk
5. Re-evaluation - continuous process of review


Sources of risk to anaesthetized patients (4)

1. Actions/inactions of anaesthetist
2. Actions/inactions of surgeon
3. Failure/malfunction of equipment
4. Organisational risks


Ways to reduce risk to patients: Anaesthetist / Surgeon related (8):

1. Training:
- competency-based training
- Formal exam-based assessments
- Appropriate supervision of trainees

2. Simulators / training devices
- Training to deal with rare life-threatening emergencies

3. Continuing medical education

4. Avoidance of fatigue
- EWTD for doctors' hours

5. Vigilance re drug/alcohol abuse

6. Anaesthetic / surgical planning

7. Checklists / guidelines and protocols
- Minimum monitoring standards (AAGBI)
- Throat packs

8. 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)


Ways to reduce risk to patients: Theatre related (3):

1. 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

2. Standardisation of hospital wristbands

3. Marking of surgical site at same time as consenting patient before leaving ward


Ways to reduce risk to patients: Anaesthetic equipment related (3):

1. Regular equipment checks - by anaesthetists, ODPs
2. Protocols: course of action if equipment fails
3. Development of equipment to reduce risks: pre-filled epidural mixtures; catheters with unique syringe connectors to avoid inadvertent iv administration of LA


Ways to reduce risk to patients: Organisation related:

1. Endure high quality employment practice (locum procedures; reviews of individual and team performance)
2. Provision of safe environment (estates, privacy)
3. Well designed policies on public envolvement
4. Regular audit and governance meetings


7 Pillars of Clinical Governance

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


Malnutrition: definition (3)

1. BMI <18.5
2. Unintentional weightloss >10% in 3-6m
3. BMI <20 with unintentional weightloss >5% in 3-6m


Malnutrition: risk factors (5)

1. Elderly
2. Alcoholism
3. Chronic illness
4. GIT surgery / disease
5. Mental illness (incl. anorexia)


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


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


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


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


Chronic alcohol abuse: CVS effects (4)

Heart failure


Chronic alcohol abuse: CNS effects (3)

Peripheral neuropathy
Autonomic dysfunction


Chronic alcohol abuse: GI effects

Oesoph / bowel CA


Chronic alcohol abuse: Metabolic effects

Low K+
Low Mg++
High urea


Chronic alcohol abuse: Heamatological effects

Low plts


Chronic alcohol abuse: MSK effects



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)


Causes of COPD (3)

Occupational exposure
Genetic causes


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


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


Smoking: Chronic CVS effects (3)

Decreased wound healing and graft success


Smoking: Chronic CNS effects

Increased risk of aneurism rupture


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


Smoking: Pre-op measures (4 headings)

1. History:
- pack-years
- Ex tol, dyspnoea, cough, sputum
- 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


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


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


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


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)


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


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.


Hepatitis: Definition + causes (4)

Def: Inflammn of liver from any cause

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


Hep B: Cause

DNA virus
Vertical transmission, blood, body secretions


Hep B: Symptoms (5)

GIT symptoms
raised LFTs


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


Sequelae of carrier state Hep B and C

Hep B: hepatic failure, hepatocellular CA

Hep C: Cirrhosis (20-30y post-exposure), hepatocellular CA


HIV: 20% of all HIV patients will have anaesthetic - commonly for (4):

Lymph node biopsies
Parital colectomies
CVP line insertion


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


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


HIV detection

anti-HIV IgG via ELISA
HIV RNA detection


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


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


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


Pre-op assessment of patient with AIDS: GIT (3)

1. D+V
2. Anorexia
3. Check + correct electrolytes


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


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


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%)


HIV: risk to anaesthetist (2)

1. Needlestick injury - 0.3%
2. Mucocutaneous transmission - 0.03%


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)


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


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


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