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Completed

NCT Number: NCT00737828

Cardiopulmonary Exercise Testing and Preoperative Risk Stratification

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London Hospitals NHS Foundation Trust, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥ 18 years age
  • Males
  • Females
  • Listed for elective(non-emergency) colorectal surgery

Exclusion criteria

  • Age < 18 years age
  • Patient unwilling/unable to consent
  • Adults with learning disabilities or dementia
  • Prisoners
  • 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
  • Patients already enrolled in an interventional study
  • Previous CPX test result recorded in the medical notes

Treatment and study plan

Perioperative care pathway guided by CPX results

Other
  • 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

Primary outcomes

  1. Postoperative morbidity (presence or absence of POMS defined morbidity)

    Time frame: Day 5

Secondary outcomes

  1. Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary

    Time frame: Day 5

  2. Total postoperative ITU bed utilisation

    Time frame: End of hospital stay i.e. day of hospital discharge

  3. Total postoperative bed utilisation

    Time frame: End of hospital stay i.e. day of hospital discharge

  4. ITU re-admission

    Time frame: End of hospital stay i.e. day of hospital discharge

  5. Death

    Time frame: Should death occur

  6. SF36 (compared with SF36 at baseline)

    Time frame: 12 months post day of surgery

Sponsors and collaborators

Lead sponsor

University College London Hospitals

Other

Collaborators

  • University Hospital Southampton NHS Foundation Trust

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Aug 20, 2008
Registry last updated
May 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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