Cardiopulmonary Exercise Testing and Preoperative Risk Stratification

Not Applicable

Completed

• Conditions: Colorectal Cancer; Anaesthesia; Critical Illness
• Interventions: Other: Perioperative care pathway guided by CPX results

• Registration Number: NCT00737828
• Lead Sponsor: University College London Hospitals

Brief Summary

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.

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2013-06
• Status Verified: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Perioperative care pathway guided by CPX results	Control - Standard Perioperative Pathway, clinician decides post-operative care environment (usual care)
B	Perioperative care pathway guided by CPX results	Intervention - Perioperative care pathway guided by CPX Results i.e.anaerobic threshold \& ventilatory equivalents

Primary Outcome Measures

Name	Time	Method
Postoperative morbidity (presence or absence of POMS defined morbidity)	Day 5

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Whittington Hospital NHS Trust; 🇬🇧 London, United Kingdom

University College London Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom

Southampton University Hospitals NHS Trust; 🇬🇧 Southampton, United Kingdom