Cardiopulmonary Exercise Testing and Preoperative Risk Stratification

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737828
• Other study ID #: 07/0114
• Secondary ID: 07/H0716/55PB-PG
• Status: Completed
• Phase: N/A
• First received: August 18, 2008
• Last updated: May 20, 2014
• Start date: August 2008
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: May 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaesthesia
• Colorectal Cancer
• Critical Illness

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals NHS Foundation Trust	London
United Kingdom	Whittington Hospital NHS Trust	London
United Kingdom	Southampton University Hospitals NHS Trust	Southampton

Sponsors (2)

Lead Sponsor	Collaborator
University College London Hospitals	University Hospital Southampton NHS Foundation Trust.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morbidity (presence or absence of POMS defined morbidity)		Day 5	No
Secondary	Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary		Day 5	No
Secondary	Total postoperative ITU bed utilisation		End of hospital stay i.e. day of hospital discharge	No
Secondary	Total postoperative bed utilisation		End of hospital stay i.e. day of hospital discharge	No
Secondary	ITU re-admission		End of hospital stay i.e. day of hospital discharge	No
Secondary	Death		Should death occur	No
Secondary	SF36 (compared with SF36 at baseline)		12 months post day of surgery	No