Clinical trial NCT00737828: Cardiopulmonary Exercise Testing and Preoperative Risk Stratification
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Anaesthesia
Critical Illness
Keywords: Cardiopulmonary exercise test
CPX
CPEX
surgical outcome
colorectal surgery
risk stratification
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: University Hospital Southampton NHS Foundation Trust
First posted: 2008-08-20
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative morbidity (presence or absence of POMS defined morbidity)
timeFrame: Day 5
Secondary outcomes:
measure: Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary
timeFrame: Day 5
measure: Total postoperative ITU bed utilisation
timeFrame: End of hospital stay i.e. day of hospital discharge
measure: Total postoperative bed utilisation
timeFrame: End of hospital stay i.e. day of hospital discharge
measure: ITU re-admission
timeFrame: End of hospital stay i.e. day of hospital discharge
measure: Death
timeFrame: Should death occur
measure: SF36 (compared with SF36 at baseline)
timeFrame: 12 months post day of surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Whittington Hospital NHS Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Southampton University Hospitals NHS Trust
Study officials:
affiliation: University College, London
name: Michael PW Grocott
role: STUDY_DIRECTOR
affiliation: University College, London
name: Paula Meale
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Michael Mythen
role: PRINCIPAL_INVESTIGATOR
affiliation: Whittington Hospital NHS Trust
name: Ayo Oshowo
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Mervyn Singer
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London Hospitals
name: Geoff Bellingan
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Kay Mitchell
role: PRINCIPAL_INVESTIGATOR
affiliation: The Whittington Hospital Hospital NHS Trust
name: Hasan Muktar
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London Hospitals
name: Alistair Windsor
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London Hospitals
name: Jim Down
role: PRINCIPAL_INVESTIGATOR
affiliation: Whittington Hospital NHS Trust
name: Martin B Kuper
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Denny ZH Levett
role: PRINCIPAL_INVESTIGATOR
affiliation: UCL
name: Phil Hennis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCL
name: Alasdair O'Doherty, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: UCLH
name: Alec Engledow
role: PRINCIPAL_INVESTIGATOR
affiliation: Whittington Hospital
name: Aundrea Mulreany
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Southampton NHS Foundation Trust
name: Carolyn Dr Way
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Southampton NHS Foundation Trust
name: Karen Linford
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Southampton NHS Foundation Trust
name: Clare Bolger
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Southampton NHS Foundation Trust
name: Paul Nichols
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Southampton NHS Foundation Trust
name: Kim Golder
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Southampton NHS Foundation Trust
name: John S Knight
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Southampton NHS Foundation Trust
name: Michael Celinski
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London Hospitals
name: Grace Adesina
role: PRINCIPAL_INVESTIGATOR
References: