SAS Pilot Protocol

SAS Pilot Protocol

Surgical Apgar Score in clinical practice: a pilot study

Version 5.2p

07/12/2010

Scientific Details......

Ethics and Governance......

Appendix 1: Summary of data to be collected......

Appendix 2: Major complication definitions and classification......

Appendix 3: Guide to site implementation......

Project Documents......

Version History......

References......

Version 5.2p | 07/12/2010| Page 1 of 24

SAS Pilot Protocol

Scientific Details

Background

Surgeons lack a routine, objective evaluation of patient condition after surgery. We currently rely on subjective assessment of available patient data. The current scoring methods such as APACHE and POSSUM are complex and cumbersomeand have therefore not been adopted into routine practice[1].

The Surgical Apgar Score (SAS) is a simple score on a scale of 0 to 10 calculated from 3 parameters collected during the operation: lowest heart rate, lowest blood pressure, estimated blood loss (Table 1).

Previous validation studies have shown a good correlation between the score and incidence of major complications or death occurring within 30 days (Table 2). To date, the SAS has never been clinically applied and tested in a trial.

We believe that routine use of the SAS will lead to a reduction in major complications and deaths after surgery. We also believe that it will lead to a reduction in the severity of the complications.

This is based on our theory that the SAS eliminates the guesswork. Using this score will add objectivity and clarity to clinical decisions that are presently based on clinical instinct or 'gut feeling'. The score will more clearly highlight those patients who are at an increased risk of developing complications or dying and will flag them up for increased monitoring, a higher index of clinical suspicion and a lower threshold for early management of problems.

Table 1. The 10-Point Surgical Apgar Scorea.

Surgical Apgar Score. No. of Points
0 / 1 / 2 / 3 / 4
Estimated blood loss, mL / >1000 / 601-1000 / 101-600 / ≤100
Lowest mean arterial pressure, mmHg / <40 / 40-54 / 55-69 / ≥70
Lowest heart rate/min / >85b / 76-85 / 66-75 / 56-65 / ≤55b

aThe Surgical Apgar Score is calculated at the end of any general or vascular surgery operation from the estimated blood loss, lowest mean arterial pressure, and lowest heart rate entered in the anaesthesia record during the operation. The score is the sum of the point from each category.

bOccurrence of pathologic bradyarrhtymia, including sinus arrest, atrioventricular block of dissociation, junctional or ventricular escape rhythms, and asystole, also receives 0 points for lowest heart rate.

Table 2. Thirty-day major complications and deaths among 4119 general and vascular surgery patients in relation to Surgical Apgar Scorea.

Score / 0-2 / 3-4 / 5-6 / 7-8 / 9-10
No. of patients / 16 / 112 / 720 / 1830 / 1441
Major complications, No. (%) / 12 (75) / 60 (54) / 201 (28) / 236 (13) / 72 (5)
Relative risk (95% CI) / 15.0
(10-5-21.5) / 10.7
(8.1-14.2) / 5.6
(4.3-7.2) / 2.6
(2.0-3.3) / 1
[Reference]
Deaths, No. (%) / 7 (44) / 18 (16) / 33 (5) / 34 (2) / 2 (0.1)
Relative risk (95% CI) / 315.2
(70.9-1401.8) / 115.8
(27.2-492.7) / 33.0
(7.9-137.2) / 13.4
(3.2-55.6) / 1
[Reference]

aMajor complication and death rates are shown according to the 10-point Surgical Apgar Score from the operation. Patients with scores of 9 or 10 served as the reference group. Risk of major complications and death decreased significantly with increasing scores (Cochran-Armitage trend test, both P<.001). CI indicates confidence interval.

Previous studies

The Surgical Apgar Score was designed in 2007 by prospectively analysing perioperative data in general or vascular surgical procedures and identifying the main influential parameters[2]. It was then validated in 2009through retrospective collection of data from general and vascular surgical procedures[3]. It was also validated in 2009 in a retrospective analysis of the score’s predictive power in radical cystectomy[4]. To date, there are no prospective studies.

Primary Aim

The primary aim of the pilot is to strengthen the design and assess the feasibility of the main study on the Surgical Apgar Score (SAS). We aim to recruit 100 patients in each group, 200 in total. The main areas to assess are:

  1. the feasibility of our protocol for the main study;
  2. the ability of the study design to achieve a clear answer to our research question;
  3. the impact and cost of the potential increased monitoring and treatment in the intervention group;
  4. the potential pitfalls and areas of bias;
  5. the accuracy of our sample size estimate for the future RCT, currently 2200.

Theprimary aim of the main study is to establish if clinical application of the SAS leads to a reduction in 30-day post-operative morbidity and mortality.

Hypothesis

The SAS facilitates clinicians in making an objective assessment of the patient’s post-operative prognosis and increase resources and attention on those with an increased risk of major complications and death, leading to better care and a decrease in the number of major complications and death.

Study Design

The design of this pilot is the same as what the RCT will eventually be: a multicentre single-blind RCT (Figure 1). This study design has been chosen as it offers the most accurate way in which to answer our research question and allows us to eliminate sources of bias. We are planning this as a multicentre trial, so that we recruit enough patients within a reasonably short time span.

Inclusion Criteria

All the following must be met:

  • Adult (18+ years)
  • General or vascular surgery
  • Emergency or elective surgery
  • Operation will require routine outpatient follow-up
  • Patient has capacity to give informed consent at the time of recruitment

Figure 1. Flowchart showing patient's progress through study.

Recruitment and Consent

The surgeons will identify the patient during the pre-operative period. Those who meet the inclusion criteria should be approached during the pre-operative consent. The trial is explained and a patient information leaflet is supplied. If possible, the patient should be given some time to think / discuss with others so as not to risk coercion. Once consent is given, the patient should sign the consent form and the surgeon should complete the registration proforma.

Operative data collection

Procedure for data collection at end of operation:

  • The surgeon will ask the anaesthetist for the required data
  • The data will be recorded by the surgeon on the proforma (this is to reduce recorder bias)

Randomisation

After operative data collection at the end of the operation the surgeon should then use the randomisation website to allocate the patient into either the control or intervention group. This is stratified by ASA grade (I-II or III-V), NCEPOD status (elective or emergency) and the hospital site to ensure balanced cofounding factors.

Blinding

Single-blinding: only the patient will be kept blind. It is not possible to build in double-blinding and observer-blinding would require a significant amount of extra resources.

Control Arm

Patients will be managed as per standard clinical care without knowledge of the SAS.

Intervention arm

The SAS will be calculated from the collected operative data. The following measures, stratified according to the score should be followed, but in all cases the surgeons and doctors will be free to exercise their own clinical judgement.

  • SAS=0-4 High risk (60%) of complications
    Discuss with ITU/HDU and request a review to consider admission
    Prescribe antibiotic, stress ulcer and DVT prophylaxis if considered beneficial
    Handover to surgical colleague to review patient at 4 and 8 hours post-op (this should specifically include review of vital signs, urine output and pain)
    Plan twice daily reviews thereafter
  • SAS=5-8 Average risk (15%) of complications
    Prescribe antibiotic, stress ulcer and DVT prophylaxis if considered beneficial
    Handover to surgical colleague to review patient at 8 hours post-op (this should specifically include review of vital signs, urine output and pain)
    Plan twice daily reviews thereafter
  • SAS=9-10 Low Risk (5%) of complications
    Manage patient as per standard clinical care

Outcomes

Outcome data will be collected by the surgeon at the follow-up clinic appointment or on a ward review if the patient is still in hospital 30 days post-op. All outcomes captured are those that occurred within 30 days of the operation. Any that occurred later than this should not be captured.

Primary outcome (within 30 days of operation):

  • Major complications or death

Secondary outcomes (within 30 days of operation):

  • Minor complications
  • Primary ITU/HDU admission and length of stay
  • Secondary ITU/HDU admission and total length of stay
  • Duration of therapeutic antibiotics
  • Number of additional operations under GA to treat complications
  • Overall length of stay
  • Performance difference between first half and second half of study (are clinicians being educated by the process and therefore improving in their overall practice?)

Lost-to-follow-up Strategy

The aim is to achieve at least 95% complete follow-up. The following strategies may be employed to achieve this. If the patient does not turn up to their clinic appointment:

  • Send out another clinic appointment
  • Telephone individually and encourage to attend clinic
  • If unsuccessful, conduct a telephone interview – if this flags up any complications then patient should be encouraged to attend clinic

Data Collection Methods

  • Consent forms will be filed in a separate confidential file and held secure in the R&D department (to comply with governance requirements).
  • Data will be collected locally on proforma sheets. As they contain patient identification details, they will be kept in confidential files in a locked cabinet in a locked room.
  • Data will be inputted into a local Microsoft Access database that will be password protected and stored on the local Trust secure servers.
  • When data collection is complete, the patient identification details will be stripped from the database before central collection, ensuring anonymity of patient, consultant and trust.

Sample Size

Current data suggests the overall expected major complication or death rate in our target population would be 21%. The sample size of the future RCT is there fore estimated to be 986 each group to detect a 5% reduction in complications (Significance 0.05%, Power 80%).

We wish to conduct a pilot study first on a sample size that is 10%, which is approximately 100 in each group, 200 in total

Analysis

Once recruitment and follow-up has been completed for 200 patients the pilot study will end and local data will be made anonymous before collating for statistical analysis.

Ethics and Governance

Ethics

This study has been reviewed and approved by East London 3 Research Ethics Committee.

Risks

There is no perceivable risk to the patient. We have been careful to design the trial so that the outcomes will be eitherthe same or better than if the patient was not to enter the trial. There will be no experimental treatment and norationing of care. The clinical staff will be permitted to exercise their usual practice without hindrance or restriction. Itis expected that those on the intervention arm will actually receive more attention and a higher level of care as a resultof the trial.

The burden on the patient is minimal as there will be no extra examinations, tests or interviews. All the data can becollected from clinical activities that are part of the current practice. The only extra activity is the initial recruitment andconsent, which should take about 15 minutes.

Safety Reporting

Should an adverse event occur as a direct result of the trial then local NHS services should be used to meet the needs of the patient. This is considered appropriate as the sponsor for the study is an NHS trust. The following actions should be taken:

  1. Assess and treat the patient with appropriate urgency using the NHS services available locally, including A&E and hospital clinical emergency systems
  2. Inform the Chief Investigator immediately on 07788723535 (24-hours, message service if no answer)
  3. Trigger local investigation by submitting a clinical incident form
  4. Inform local R&D department

Costs

The total cost that needs to be met is £270. Our cost analysis has been performed using the Barts & The London costing template and a breakdown is shown in Table 3.

At this stage it is very hard to predict how much effect the SAS will have on the clinical decisions. We do not know if, as a result of the trial, patients will receive more or less treatment. Therefore it is very difficult to estimate if there will be additional costs for supporting patient care and if there will be any excess treatment. This section on the finance form has been left blank. We will have a better idea of these potential costs after this pilot study.

The staffing costs of the project (Table 4) are already met. The investigators all have time in their weekly schedule formally allocated to research and study as part of their contracts. This time will be donated to the project.

Table 3. Costs needing to be met.

Item / Cost
Statistician / £120
Randomisation Website / £0
Stationary / £100
Archives / £50
Total / £270

Table 4. Costs already met.

Item / Cost
Investigator (Registrar) / £8,300
Investigator write-up / £1,244
Total / £9,544

Funding

Funding application to National Institute for Health Research Research for Patient Benefit competition 12 was unsuccessful. The pilot study can still continue as the costs needing to be met are minimal and can be absorbed within existing department budgets.

Project Management

The project is being run by the London Surgical Research Group. We are a research network of 180 members that is led by higher surgical trainees in London, and headed by Mr Charles Knowles, Senior Lecturer and Honorary Consultant, Academic Surgical Unit, Centre for Digestive Diseases, Institute for Cell and Molecular Science, Barts and The London School of Medicine and Dentistry. By working together, trainees who as part of their training are placed in various hospitals across London and the South East, can use this network to facilitate large multicentre studies on surgical research topics. This allows the collection of large amounts of data in a relatively short period of time, leading to statistically powerful results.

The group's steering committee meets every month to discuss the progress of the project, identifying issues and sticking points causing delays and areas that require attention, resources or management. There is also direct liaison between the Chief Investigator and the Director of the lead R&D office (Barking, Havering and Redbridge University Hospitals NHS Trust) to ensure all governance standards are met. The lead organisation R&D and finance offices will provide financial management.

Methods of Disseminating Findings

We will disseminate our findings through academic and public channels: presentation at Association of Surgeons of Great Britain and Ireland annual scientific conference, presentation at the Patient Safety Congress sponsored by the NPSA, submission for publication in the British Journal of Surgery, and e-newsletter to participants who subscribe to the mailing list.

Project Timeline

The project timeline can be seen in Figure 2.

Project Management Information

Main Investigation Team
Chief Investigator / Mr Sabu Jacob
Study Co-ordinator / Mr James Haddow
Principal Investigator (KGH) / Mr Wayne Chicken
Principal Investigator (QH) / Miss Rachel Aguilo
Principal Investigator (NMH) / Mr James Haddow
Principal Investigator (HUH) / Mr Salim Tayeh
Project Supervisor / Mr Charles Knowles
Lead R&D & Sponsor / Barking Havering & Redbridge University Hospitals NHS Trust
Lead R&D Director / Professor Jayanta Barua
Lead R&D Contact / Mr Ian Laskey
R&D Coordinator, Queen’s Hospital, Rom Valley Way, Romford, Essex RM7 0AG
T: 01708 435306
F: 01708 435305
E:
Barking, Havering & Redbridge University Hospitals NHS Trust (lead R&D and sponsor)
Hospitals involved / King George Hospital (KGH), Barley Lane, London IG3 8YB
Queen’s Hospital (QH), Rom Valley Way, Romford, Essex RM7 0AG
Principal Investigator (KGH) / Mr Wayne Chicken
Principal Investigator (QH) / Miss Rachel Aguilo
Site Supervisor (KGH) / Mr Sabu Jacob
R&D Contact / Mr Ian Laskey
R&D Coordinator, Queen’s Hospital, Rom Valley Way, Romford, Essex RM7 0AG
T: 01708 435306
F: 01708 435305
E:
North Middlesex University Hospital NHS Trust
Hospitals involved / North Middlesex University Hospital (NMUH), Sterling Way, London N18 1QX
Principal Investigator / Mr James Haddow
Site Supervisor (KGH) / Mr Luke Meleagros
Local Collaborators / Mr Hussam Adwan
Dr Christine Gan
R&D Contact / Mr Steven Roberts
R&D Coordinator, North Middlesex University Hospital, Sterling Way, London N18 1QX
T: 020 8887 2307
E:
Homerton University Hospital NHS Foundation Trust
Hospital involved / Homerton University Hospital (HUH), Homerton Row, London E9 6SR
Principal Investigator / Mr Salim Tayeh
Local Collaborator / Dr Miriam Adebibe
Site Supervisor / Mr Charles Knowles
R&D Contact / Chameli Uddin
R&D Administrator, Small Office, Blue Roof Homerton University Hospital, Homerton Row, London E9 6SR
T: 020 8510 5501
F: 020 8510 7850
E:
Imperial College Healthcare NHS Trust
Hospital involved / St Mary’s Hospital (SMH), Praed Street, London W2 1NY
Principal Investigator / Ms Parveen Jayia
Site Supervisor / Mr Richard Gibbs
R&D Manager / Mr Richard Abbott
R&D Contact / Susana Murphy
Research Governance Administrator, R&D Department, Imperial College Healthcare NHS Trust, St Mary’s Hospital, Mailbox 121, Praed Street, London W2 1NY
T: 020 3312 6484
F: 020 3312 1529
E:

Contacts Information

Name and post held / Contact information
Mr Charles Knowles
Senior Lecturer in Colorectal Surgery and Honorary Colorectal Surgeon, Barts & the London NHS Trust and Homerton University Hospital NHS Foundation Trust / Academic Surgical Unit, 3rd Floor Alexandra Wing, Royal London Hospital, Whitechapel, LondonE11BB
T: 020 7882 8757
M: 07866 586766
F: 020 7377 7346
E:
Dr Miriam Adebibe
CT3, General Surgery / Academic Unit of Medical & Surgical Gastroenterology, Homerton University Hospital, Homerton Row, London E9 6SR
T: 020 8510 7981
M: 07773 756836
E:
Mr Salim Tayeh
Senior Clinical Fellow, General Surgery / Academic Unit of Medical & Surgical Gastroenterology, Homerton University Hospital, Homerton Row, London E9 6SR
T: 020 8510 7981
M: 07867 895385
E:
Mr Sabu Jacob
Consultant Vascular & General Surgeon / Department of General Surgery, King George Hospital, Barley Lane, London IG3 8YB
T: 020 8970 8058
E:
Mr Wayne Chicken
SpR, General Surgery / Department of General Surgery, King George Hospital, Barley Lane, London IG3 8YB
T: 020 8983 8000
E:
Dr Christine Gan
CT1, General Surgery / Department of General Surgery, North Middlesex University Hospital, Sterling Way, London N18 1QX
T: 020 8887 2000
E:
Mr Hussam Adwan
SpR, General Surgery / Department of General Surgery, North Middlesex University Hospital, Sterling Way, London N18 1QX
T: 020 8887 2000
M: 07810 774499
E:
Mr James Haddow
Specialist Registrar, General Surgery / Department of Colorectal Surgery, North Middlesex University Hospital, Sterling Way, London N18 1QX
T: 020 8887 2000
M: 07788 723535
E:
Mr Luke Meleagros
Consultant Colorectal and Laparoscopic Surgeon, General Surgery / Department of General Surgery, North Middlesex University Hospital, Sterling Way, London N18 1QX
T: 020 8887 2000
E:
Miss Rachel Aguilo
Specialist Registrar, General Surgery / Department of Surgery, Queen’s Hospital, Rom Valley Way, Romford, Essex RM7 0AG
M: 01708 435000
E:
Mr Richard Gibbs
Consultant Vascular Surgeon / Department of Vascular Surgery, St Mary’s Hospital, Praed Street, London W2 1NY
T: 020 7886 3726
F: 020 7886 2216
Ms Parveen Jayia
Core Surgical Trainee, Vascular Surgery / Department of Vascular Surgery, St Mary’s Hospital, Praed Street, London W2 1NY
T: 020 7886 6528
E:

Authorship