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Cardiopulmonary Exercise Testing and Preoperative Risk Stratification

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737828
First Posted: August 20, 2008
Last Update Posted: May 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital Southampton NHS Foundation Trust
Information provided by (Responsible Party):
Mike Grocott, University College London Hospitals
  Purpose
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.

Condition Intervention
Colorectal Cancer Anaesthesia Critical Illness Other: Perioperative care pathway guided by CPX results

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mike Grocott, University College London Hospitals:

Primary Outcome Measures:
  • Postoperative morbidity (presence or absence of POMS defined morbidity) [ Time Frame: Day 5 ]

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

Enrollment: 228
Study Start Date: August 2008
Study Completion Date: May 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737828


Locations
United Kingdom
Whittington Hospital NHS Trust
London, United Kingdom, N19 5NF
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2BU
Southampton University Hospitals NHS Trust
Southampton, United Kingdom
Sponsors and Collaborators
University College London Hospitals
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 NHS Foundation Trust
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 NHS Foundation Trust
Principal Investigator: Jim Down University College London Hospitals NHS Foundation Trust
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 NHS Foundation Trust
  More Information

Responsible Party: Mike Grocott, Professor, University College London Hospitals
ClinicalTrials.gov Identifier: NCT00737828     History of Changes
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) )
First Submitted: August 18, 2008
First Posted: August 20, 2008
Last Update Posted: May 21, 2014
Last Verified: May 2014

Keywords provided by Mike Grocott, University College London Hospitals:
Cardiopulmonary exercise test
CPX
CPEX
surgical outcome
colorectal surgery
risk stratification

Additional relevant MeSH terms:
Colorectal Neoplasms
Critical Illness
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes