Cardiopulmonary Exercise Testing and Preoperative Risk Stratification

A Randomised Controlled Trial of the Utility of Cardiopulmonary Exercise (CPX) Testing for Preoperative Risk Stratification to Guide Perioperative Care and Thereby Reduce Postoperative Morbidity

The investigators would like to evaluate the use of cardiopulmonary exercise tests (CPX) in guiding the care pathway of patients undergoing colorectal operations. In the intervention group care will be guided by CPX results and in the control group care will be guided by the doctors assessment. The investigators would like to assess the impact of this on patient outcome, patient satisfaction and resource usage.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Anaesthesia; Colorectal Cancer
• Intervention / Treatment: Other: Perioperative care pathway guided by CPX results

Detailed Description

Each year 20000 UK patients die within 30 days of surgery. It seems that in the UK a patient's chances of becoming seriously unwell or dying following surgery is higher than in comparable countries. Fewer beds in the UK are given over to Intensive Care than in these other countries. Closer attention to the care given after operations, which can be achieved on intensive care units (ICU), almost certainly reduces the chances of serious illness following major surgery. An increase in the number of intensive care unit beds in the UK is extremely unlikely. Better use of the available intensive care beds could be achieved by allocating them where they are believed to improve outcome (following surgery) and by allocating them to patients most likely to benefit.

Tests used to assess risk of surgery to patients are largely ineffective. Cardiopulmonary exercise tests (CPX) seem to be effective at identifying patients at risk of death or serious illness post surgery. This information has been used in studies to select patients for ICU beds and reduce deaths. The studies so far have limitations in their design and scope which means we can't be certain this approach works in the UK.

We suggest a study to answer this question more conclusively and more specifically in UK patients. We will randomly divide patients between two groups. In the 1st group choice of postoperative care environment is based on best current practice and in the other group we will make these decisions (critical care or ward) based on the results of the CPX.

We hope that the benefits will include less patients becoming seriously ill or dying and shorter stays in hospital after surgery following major operations. We also hope the information will help patients understand the risks of their operation better and therefore make better informed decisions. This may also reduce the overall cost of surgery for hospitals.

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2BU
    • University College London Hospitals Nhs Foundation Trust
  • London, United Kingdom, N19 5NF
    • Whittington Hospital NHS Trust
  • Southampton, United Kingdom
    • Southampton University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adults ≥ 18 years age
2. Males
3. Females
4. Listed for elective(non-emergency) colorectal surgery

Exclusion Criteria:

1. Age < 18 years age
2. Patient unwilling/unable to consent
3. Adults with learning disabilities or dementia
4. Prisoners

5. Any contraindication to cardiopulmonary exercise testing (as outlined by *American Association of Anaesthesia:

   • Acute MI (3-5 days)
   • Unstable angina
   • Uncontrolled arrhythmias
   • Syncope
   • Acute endocarditis
   • Acute myocarditis
   • Acute pericarditis
   • Symptomatic severe aortic stenosis
   • Uncontrolled heart failure
   • Acute pulmonary embolism or infarction
   • Thrombosis of lower extremities
   • Dissecting aneurysm
   • Uncontrolled asthma
   • Pulmonary oedema
   • Room air desaturation at rest <85%
   • Respiratory failure
   • Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise Mental impairment leading to inability to co-operate
6. Patients already enrolled in an interventional study
7. Previous CPX test result recorded in the medical notes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Control - Standard Perioperative Pathway, clinician decides post-operative care environment (usual care)	Other: Perioperative care pathway guided by CPX results; AT > 11ml/min/kg no myocardial ischaemia or Ve/VO2 <35 - Level 1 Ward Care; AT > 11ml/min/kg with myocardial ischaemia or Ve/VO2 >35 - Level 2/3 (ITU) Critical Care Unit; AT <11mls/min/kg - Level 2/3 Critical Care Unit; AT <8mls/min/kg - Level 2/3 Critical Care Unit/ consider cancellation or alternative procedure
Experimental: B; Intervention - Perioperative care pathway guided by CPX Results i.e.anaerobic threshold & ventilatory equivalents	Other: Perioperative care pathway guided by CPX results; AT > 11ml/min/kg no myocardial ischaemia or Ve/VO2 <35 - Level 1 Ward Care; AT > 11ml/min/kg with myocardial ischaemia or Ve/VO2 >35 - Level 2/3 (ITU) Critical Care Unit; AT <11mls/min/kg - Level 2/3 Critical Care Unit; AT <8mls/min/kg - Level 2/3 Critical Care Unit/ consider cancellation or alternative procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative morbidity (presence or absence of POMS defined morbidity)	Day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary	Day 5
Total postoperative ITU bed utilisation	End of hospital stay i.e. day of hospital discharge
Total postoperative bed utilisation	End of hospital stay i.e. day of hospital discharge
ITU re-admission	End of hospital stay i.e. day of hospital discharge
Death	Should death occur
SF36 (compared with SF36 at baseline)	12 months post day of surgery

Collaborators and Investigators

• Sponsor: University College London Hospitals
• Collaborators: University Hospital Southampton NHS Foundation Trust
• Investigators: Study Director: Michael PW Grocott, University College, London; Principal Investigator: Paula Meale, University College, London; Principal Investigator: Michael Mythen, University College, London; Principal Investigator: Ayo Oshowo, Whittington Hospital NHS Trust; Principal Investigator: Mervyn Singer, University College, London; Principal Investigator: Geoff Bellingan, University College London Hospitals; Principal Investigator: Kay Mitchell, University College, London; Principal Investigator: Hasan Muktar, The Whittington Hospital Hospital NHS Trust; Principal Investigator: Alistair Windsor, University College London Hospitals; Principal Investigator: Jim Down, University College London Hospitals; Principal Investigator: Martin B Kuper, Whittington Hospital NHS Trust; Principal Investigator: Denny ZH Levett, University College, London; Principal Investigator: Phil Hennis, PhD, UCL; Principal Investigator: Alasdair O'Doherty, MSc, UCL; Principal Investigator: Alec Engledow, UCLH; Principal Investigator: Aundrea Mulreany, Whittington Hospital; Principal Investigator: Carolyn Dr Way, University Hospital Southampton NHS Foundation Trust; Principal Investigator: Karen Linford, University Hospital Southampton NHS Foundation Trust; Principal Investigator: Clare Bolger, University Hospital Southampton NHS Foundation Trust; Principal Investigator: Paul Nichols, University Hospital Southampton NHS Foundation Trust; Principal Investigator: Kim Golder, University Hospital Southampton NHS Foundation Trust; Principal Investigator: John S Knight, University Hospital Southampton NHS Foundation Trust; Principal Investigator: Michael Celinski, University Hospital Southampton NHS Foundation Trust; Principal Investigator: Grace Adesina, University College London Hospitals

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 18, 2008
• First Submitted That Met QC Criteria: August 19, 2008
• First Posted (Estimate): August 20, 2008

Study Record Updates

• Last Update Posted (Estimate): May 21, 2014
• Last Update Submitted That Met QC Criteria: May 20, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: colorectal surgery; risk stratification; Cardiopulmonary exercise test; CPEX; surgical outcome; CPX
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 07/0114; 07/H0716/55 (Other Identifier: NHNN REC Number); PB-PG-0906-11426 (Other Grant/Funding Number: UK National Institute of Health Research (NIHR))