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Welsh Anaesthetic Trainees Journal Club

Month

April 2018

Journal Club: 25th April 2018

Effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: cluster controlled trial with randomised stepped-wedge implementation

BMJ Open 2018;8:e017781. doi:10.1136/ bmjopen-2017-017781

Presented by: Dr G Roberts

Background

Perioperative care is often a fragmented process between disciplines, patients, clinicians and hospitals.  A proof of concept trial had previously demonstrated in gynaecological care that an internet-based peri-operative care platform could potentially empower patients during this period; the aim to enhance post-operative recovery through appropriate self-management strategies, reduce inappropriate recovery behaviour and ultimately enable a quicker return to work.

Design & Setting

  • Three year (2011 to 2014) study sequentially across nine hospitals using a stepped-wedge cluster randomised trial (https://www.bmj.com/content/350/bmj.h391)
  • Eligible hospitals had to perform at least 100 hysterectomies or laparoscopic adnexal surgery. Hospitals served as the control group until the care programme was sequentially implemented.
  • Study design did not allow for blinding, but group allocation was concealed from patient until consent obtained. Data analysts blinded.

Subjects

Over 400 employed women aged between 18 – 65 scheduled for surgery of benign gynaecological disease.

Inclusion

  • Scheduled for hysterectomy (vaginal, laparoscopic or abdominal) and/or laparoscopic adnexal surgery.
  • Aged between 18 – 65.
  • Employed for at least eight hours a week.

Exclusion

  • Severe benign comorbidity or malignancy.
  • Pregnancy
  • Computer or internet illiterate.
  • Insufficient command of Dutch language.

Intervention

Internet-based care programme sequentially rolled out using a multifaceted implementation strategy. Patients were allocated to either the care programme (intervention) or usual care (control).  The care programme included an e-health intervention equipping patients with tailored personalised convalescence advice that had been designed by patients, gynaecologists, GPs and occupational physicians. Post-operatively, the web portal contained an interactive self-assessment tool to monitor recovery.

Outcomes

Primary

  • Sick leave duration until full sustainable return to work (defined as the resumption of own work or other work with equal earnings, for at least four weeks without recurrence of sick leave).

Secondary

  • Functional health status
  • Recovery
  • Self-efficacy
  • Coping
  • Pain

 Results

  • 433 participants recruited from potentially 1591.
  • Data for primary outcome obtained from 401 participants while data for secondary outcomes obtained from 334 participants.
  • 8% of participants in intervention group used the website programme as intended.
  • Median duration until full sustainable return to work was 49 days in intervention group and 62 days in control group.
  • No demonstrable difference in functional health status, self-efficacy and coping.

 Conclusions

The use of internet-based information technology to facilitate a gynaecology patient’s perioperative journey may result in a reduction in post-operative sick days.  It would be worth other surgical specialties adopting and evaluating this method, while identifying those patients who might benefit most from this approach.

Strengths

  • Assessment of both patient and organisation.
  • Intention-to-treat.
  • Sub-group analysis.

Weaknesses

  • Cluster design may have led to recruitment bias.
  • The online platform had a proof of concept but not necessarily validated.
  • Just under a third of eligible patients were recruited, the majority of whom either declined to participate or were not eligible.
  • Due to the eligibility criteria requiring employed women who were computer literate, a high proportion of participants were deemed highly educated – How can conclusions apply across the general population?
  • There was significantly more loss-to-follow up in the intervention group.

Implications

  • There is a potentially large positive bio-psycho-social impact if these results are proved to be reproducible.
  • Reduction in sick days would have a positive socio-economic effect.

 Potential for impact

With more focus and energy being applied to the process of perioperative care by many stakeholders and the increasing use of information technology, this approach may prove to empower patients during their perioperative journey and lead to better recovery profiles.  Care is needed however to ensure that there is more to recovery than simply ‘return to work’.

Journal Club: 18th April 2018

Normal saline versus a balanced crystalloid for goal-directed perioperative fluid therapy in major abdominal surgery: a double-blind randomised controlled study

British Journal of Anaesthesia 2018;120(2):274-283

Presented by: Dr I Rees

Background

  • Normal saline 0.9% amongst most commonly used crystalloid for fluid therapy
  • However normal saline not ‘normal’
    • Sodium and chloride concentrations 154mmol/l
    • Risk of hyperchloraemic metabolic acidosis and reduced anion gap
    • Linked to increased risk of renal dysfunction, transfusion and mortality in patients undergoing abdominal surgery
  • Balanced crystalloids contain metabolisable anions (lactate or acetate)
    • Maintain electrolyte stability
    • Less associated with metabolic acidosis
    • Metabolised to bicarbonate
  • Recent study in same centre demonstrated patients undergoing cadaveric renal transplantation required significantly less catecholamine support if receiving balanced crystalloid, compared to the group receiving normal saline
  • Authors hypothesised that patients undergoing major surgery might require less vasopressor support if they received a balanced crystalloid, as opposed to normal saline perioperatively

Design & Setting

  • Single-centre (Department of Anaesthesiology of the Medical University of Vienna, Austria)
  • Prospective double-blinded randomised controlled study of patients undergoing elective major abdominal surgery
  • Patients and anaesthetists blinded
  • Ethics approved
  • Sample size calculated (based on previous transplantation study) – 120 patients per group (240 total) to give α 5% and 80% power

Subjects

Inclusion criteria:

  1. Adult, non-pregnant patients
  2. Undergoing elective major abdominal surgery (any general, gynaecological or urological procedure requiring laparotomy)

Exclusion criteria:

  1. LV ejection fraction <30%
  2. Renal dysfunction (GFR <30ml/min) and severe liver disease
  3. Chronic inflammatory diseases requiring long-term steroids
  4. Pre-operative sepsis or critical care patients
  5. Contraindications to oesophageal doppler
  6. Intraoperative epidural analgesia

Intervention

  • Patients randomised on day of surgery to receive either normal saline or a chloride-reduced acetate-buffered balanced crystalloid (Elomel Isoton)
  • No pre-operative fluid infusion
  • Blinded fluids given to anaesthetist before induction of anaesthesia
  • Standardised anaesthetic:
    • Standardised induction (propofol 2-3mg/kg, rocuronium 0.6mg/kg and fentanyl 2-3mcg/kg)
    • Standard monitoring including arterial line and CVP + depth of anaesthesia monitoring (Narcotrend), train-of-four ulnar montoring and oesophageal doppler (CardioQ)
    • Sevoflurane administration according to Narcotrend; FiO2and fentanyl boluses according to clinical requirement; Rocuronium to maintain one or two twitches on TOF
    • Ventilation to maintain end-tidal CO2 near 35mmHg (~4.6kPa) – tidal volume 8-10ml/kg (LBW), peak pressure <30mmHg (~40cmH2O) and PEEP of 5mmHg (~7cmH2O) or higher according to patient need.
    • Temperature >36oC using forced air warmer and hourly arterial blood gases
    • Fluid maintenance 2ml/kg/hr (IBW as per Robinson’s formula) increased to 5ml/kg/hr on exposure of viscera
  • Target MAP according to pre-operative blood pressure the day before surgery:
Pre-operative Blood Pressure (mmHg) Intraoperative Target MAP (mmHg)
Hypotensive SBP <120 60
Normotensive SBP 120-139 / DBP 80-89 70
Hypertensive SBP >140 / DBP >90 80
  • If MAP fell, standardised protocol followed:
    • SV responsiveness assessed using 250ml fluid challenge
    • If >10% increase in SV but MAP still below desired value, further 250ml boluses until SV increase <10% or target MAP achieved
    • If target MAP still not achieved and SV ‘unresponsive’, phenylephrine 0.1-0.2mcg bolus given (maximum 0.8mcg/hr)
    • If still insufficient, noradrenaline infusion started at 0.01-0.02 mcg/kg/min and titrated to desired MAP by increments of 0.05-0.1mcg/kg
    • If SV fell by >10% of the value following the last fluid challenge, a further 250ml was given
    • Noradrenaline titrated down or stopped if fluid challenges sufficient in maintaining MAP
  • Exit criteria: pH below 7.2, bicarbonate below 14mmol/l, base excess below -10mmol/l or response to catecholamines insufficient – fluid changed to balanced crystalloid and study was terminated.

Outcomes

Primary:

  1. Need for vasopressors

Secondary:

  1. Total dose of catecholamines
  2. Total perioperative fluid
  3. Unplanned intensive care admissions

Results

  • Terminated early for safety reasons (hyperchloraemic metabolic acidosis) after discussion with study safety board and local authority
  • Only 60 of the total planned 240 were studied (30 in each group)
  • More patients required vasopressors in the normal saline group than the balanced crystalloid (97% vs67% respectively,p=0.033)
  • Median weight and duration-adjusted dose of norepinephrine were 0.11(0.00-0.45)mcg/kg/min in the normal saline group compared with 0.00mcg/kg/min in the balanced crystalloid group (p=0.003)
  • No difference between groups in total perioperative fluid and unplanned intensive care admissions
  • Cox regression showed need for vasopressors related to high volume of administered fluid, normal saline resuscitation and lower MAP

Conclusions

  • Study suggests that patients undergoing major abdominal surgery with normal saline fluid therapy have a significantly larger vasopressor requirement than those receiving a more physiological crystalloid.
  • Hyperchloraemia with or without acidosis may be a direct trigger for unfavourable cardiovascular effects – leads to increased nitric oxide, as seen in rats

Strengths

  • Focused question asked
  • Hypothesis based on previous study
  • Prospective double-blinded RCT
  • Patient groups comparable
  • Appropriate inclusion and exclusion criteria
  • Extremely standardised protocol
  • Appropriate statistical analysis i.e. Mann-Whitney U Test for quantitative, non-parametric analysis of 2 unpaired groups

Weaknesses

  • Terminated due to patient safety
  • Underpowered (67%) for primary outcome due to low numbers – power 90% for secondary outcomes
  • Single-centre
  • Protocol resulted in large amounts of intraoperative fluid infusion (median 3427ml of normal saline and 3144 of the balanced crystalloid)
  • No mention of blood products
  • No epidural or intrathecal block
  • Is it an important clinical question?

Implications/Potential for impact

  • Is our practice likely to change following this study?
  • Inference that normal saline may cause detrimental cardiovascular effects due to hyperchloraemic acidosis (leading to increased nitric oxide, as seen in rats) is interesting
  • Vast majority of anaesthetists likely to use a balanced crystalloid e.g Hartmann’s solution, rather than normal saline for elective adult surgery (save for a few circumstances e.g. liver failure etc) as it is more ‘physiological’ – why cause further stress during the stress response?

Following this underpowered study that put patients in harm’s way, I will do as the authors suggest i.e. exactly what I’ve been doing this entire time.

Journal Club: 11th April 2018

Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery. A Randomised Blinded Controlled Trial.

 Annals of Surgery 2018;267(1):50-56 doi:10.1097/SLA.0000000000002293

Presented by: Rebeca Harris ST4

Background

  • Major abdominal surgery is associated with a high rate of postoperative complications, particularly in elderly patients with multiple comorbidities.
  • Aerobic capacity determines postoperative functional reserve, which is negatively associated with postoperative morbidity and mortality.
  • Prehabilitation exercise programmes are postulated to improve aerobic capacity, and thereby reduce postoperative complications.
  • Previous studies have shown a bias towards low-risk patients, and lack of evidence on postoperative clinical outcomes.
  • Prehabilitation is defined as a preparatory intervention aiming to increase aerobic capacity. Methods include supervised endurance exercise training and the promotion of physical activity.

Design & Setting

  • Single centre: Hospital Clinic de Barcelona
  • Patients were blindly randomized
  • Collaborating anaesthetists and surgeons were blinded to patient’s allocation
  • Ethics approved
  • Sample size prospectively powered (as standard, accepting risks of: α 0.05 and β 0.2), based on:
    • the reduction rate of patients with postoperative complications as the main outcome
    • considering the local colorectal complication rate (30%), and
    • anticipating up to 20% drop out
    • Intention-to-treat analysis

Subjects

High risk patients for elective major abdominal surgery

Inclusion criteria:

  • Elective major abdominal surgery
  • High risk defined by all of the following:
    • Age > 70 and/or ASA III/IV
    • Duke Activity Status Index Score < 46
    • Preop schedule allowed at least 4 weeks for the prehabilitation intervention

Exclusion criteria:

  • Non-elective surgery
  • Unstable cardiorespiratory disease
  • Locomotor limitations precluding exercise training
  • Cognitive deterioration impeding adherence to the programme

Intervention

  • Baseline assessment within 1 week of preoperative assessment
  • Reassessment 1 week before surgery

Standard care:

  • Physical activity, nutritional and smoking cessation advice
  • IV iron if indicated for anaemia
  • Nutritional intervention if high-risk for malnutrition

Intervention:

  • Personalised prehabilitation programme based on health and social circumstances
  • Mostly community based
  • 3 major aspects
    • Motivational interview to assess adherence profile. Tailored physical activity programme then co-designed with the patient
    • Personalised daily physical activity programme
      • Pedometer to measure steps, then feedback and optimization
    • Supervised high intensity endurance exercise programme
      • 1-3 per week
      • Exercise bike interval training, tailored to increase intensity over time, based on work rate
      • Pulse oximetry and self-perceived exertion measured

Outcomes

Primary

  • Number of patients with a complication

Secondary

  • Number and severity of postoperative complications
  • Hospital and ICU length of stay

Other

  • Endurance time
  • Distance covered in 6 minute walking test
  • Physical activity (by validated patient survey)
  • Self perceived health status (by validated patient survey)
  • Psychological status (by HADS patient survey)
  • Pulmonary function tests
  • Cardiorespiratory exercise tests

 Results

Baseline characteristics

  • 209 assessed over 3 years – 144 eligible and randomised (> 70 per group, as per power analysis minimum)
  • Comparable patient characteristics between groups
  • 19 did not receive operation, so excluded mid-trial
  • Control: 1 unable to perform exercise testing, 6 abandoned
  • Intervention: 4 unable to perform exercise testing, 4 abandoned
  • 56 (Control) and 54 (Intervention) completed trial (< 70 per group, and > 20% dropout rate, thus underpowered)

 Control

  • No change in baseline characteristics at start vs 1 week pre-surgery

 Prehabilitation intervention

  • Mean duration 6 weeks + 12 supervised exercise session
  • PRMIARY OUTCOME
    • 50% reduction in number of patients with complications: 31% vs 62%, RR 0.5 (95% CI 0.3-0.8), p = 0.001
  • SECONDARY OUTCOMES:
    • Increasein Endurance Time (135%, p < 0.001)
    • Increasein Physical Activity Index (37 points, p< 0.001)
    • No significant difference in intraoperative parameters, but trend towards lower requirement of vasoactive drugs (p=0.053)
    • Lower mean number of complications per patient : Cardiovascular(p = 0.03, RR 0.1, 95% CI 0.1-1.0), Infection of uncertain source (p = 0.013, RR not possible), Paralytic ileus (p = 0.001, RR not possible)
    • In patients with complications, intervention reducedrisk of having more than one complication (RR 0.6, but 95% CI 0.3-1.1), but no effect on severity of complications.
    • Reduced length of ICU stay (3 vs 12 days, p = 0.046)

 Conclusions

  • High intensity endurance exercise training is feasible and safe in elderly and/or multimorbid candidates for major abdominal surgery
  • Prehabilitation enhanced clinical outcomes in high-risk candidates for elective major abdominal surgery, which can be explained by the increase in aerobic capacity
  1. Reduced complication rate
  2. Prevents > 1 complication
  3. Reduced ICU length of stay

Strengths

  • Randomised blinded controlled trial
  • High risk patient group selected, reflecting patient population
  • Initially adequately powered
  • Performed within realistic preoperative timeframe for urgent surgery
  • Highly personalised, patient-centred prehabilitation programme. Well detailed for reproducibility
  • Interesting secondary outcomes, validated tools used
  • Appropriate statistical analysis employed
  • Number of patients abandoning intervention arm < control, thus patient engagement good

Weaknesses

  • Single centre
  • Blinding of clinicians following interaction with patients may have been difficult
  • Underpowered following dropouts – still able to demonstrate statistically significant difference in primary outcome, however may have ‘missed’ other significant differences in secondary outcomes
  • ? Blinding of exercise tester
  • Primary outcome extremely broad – ‘any complications’ postoperatively. Not specific, and therefore clinical significance and importance of question reduced.
  • Survival and functional recovery not assessed
  • Underpowered to assess effect on specific and important post operative complications
  • Did not demonstrate a difference in the severity of postoperative complications
  • Claims significant reduction in CV complications and the number of patients having > 1 complication, but:
    • Reduction in CV complications 95% CI 0.1-1, wide and includes ‘no effect’
    • Reduction in number of patients having more than 1 complication 95% CI 0.3-1.1, wide and includes ‘no effect’
  • Endurance time rather than familiar, objective CPEX data e.g. Anabolic threshold, formed basis of measure of aerobic capacity
  • Intensive, highly tailored programme
    • ? Sustainability on larger scale
    • No cost analysis

Implications

  • Prehabilitation in elderly, multimorbid patients appears to be feasible, safe and ‘acceptable’ to patients
  • Prehabilitation can increase preoperative exercise endurance in high risk patients
  • Postoperative complication rates can be reduced by this strategy
  • However, larger trials are required to further characterise and assess the clinical significance of postoperative complication benefits, and to determine the effect on functional recovery and survival

Potential for impact

  • Important step towards assessing the potential benefits and characterising the design of prehabilitation exercise programmes in high risk patients undergoing high risk elective surgery
  • Important and exciting emerging field of research with potential for significantly improving patient outcomes

 

 

 

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