Cardiopulmonary Exercise Testing and Preoperative Risk Stratification
Primary Purpose
Colorectal Cancer, Anaesthesia, Critical Illness
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Perioperative care pathway guided by CPX results
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Cardiopulmonary exercise test, CPX, CPEX, surgical outcome, colorectal surgery, risk stratification
Eligibility Criteria
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
Sites / Locations
- Whittington Hospital NHS Trust
- University College London Hospitals NHS Foundation Trust
- Southampton University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
Control - Standard Perioperative Pathway, clinician decides post-operative care environment (usual care)
Intervention - Perioperative care pathway guided by CPX Results i.e.anaerobic threshold & ventilatory equivalents
Outcomes
Primary Outcome Measures
Postoperative morbidity (presence or absence of POMS defined morbidity)
Secondary Outcome Measures
Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary
Total postoperative ITU bed utilisation
Total postoperative bed utilisation
ITU re-admission
Death
SF36 (compared with SF36 at baseline)
Full Information
NCT ID
NCT00737828
First Posted
August 18, 2008
Last Updated
May 20, 2014
Sponsor
University College London Hospitals
Collaborators
University Hospital Southampton NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00737828
Brief Title
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
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College London Hospitals
Collaborators
University Hospital Southampton NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Anaesthesia, Critical Illness
Keywords
Cardiopulmonary exercise test, CPX, CPEX, surgical outcome, colorectal surgery, risk stratification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Control - Standard Perioperative Pathway, clinician decides post-operative care environment (usual care)
Arm Title
B
Arm Type
Experimental
Arm Description
Intervention - Perioperative care pathway guided by CPX Results i.e.anaerobic threshold & ventilatory equivalents
Intervention Type
Other
Intervention Name(s)
Perioperative care pathway guided by CPX results
Intervention Description
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 Outcome Measure Information:
Title
Postoperative morbidity (presence or absence of POMS defined morbidity)
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary
Time Frame
Day 5
Title
Total postoperative ITU bed utilisation
Time Frame
End of hospital stay i.e. day of hospital discharge
Title
Total postoperative bed utilisation
Time Frame
End of hospital stay i.e. day of hospital discharge
Title
ITU re-admission
Time Frame
End of hospital stay i.e. day of hospital discharge
Title
Death
Time Frame
Should death occur
Title
SF36 (compared with SF36 at baseline)
Time Frame
12 months post day of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael PW Grocott
Organizational Affiliation
University College, London
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paula Meale
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Mythen
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayo Oshowo
Organizational Affiliation
Whittington Hospital NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mervyn Singer
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geoff Bellingan
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kay Mitchell
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hasan Muktar
Organizational Affiliation
The Whittington Hospital Hospital NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alistair Windsor
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jim Down
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin B Kuper
Organizational Affiliation
Whittington Hospital NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denny ZH Levett
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phil Hennis, PhD
Organizational Affiliation
UCL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alasdair O'Doherty, MSc
Organizational Affiliation
UCL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alec Engledow
Organizational Affiliation
UCLH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aundrea Mulreany
Organizational Affiliation
Whittington Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolyn Dr Way
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Linford
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clare Bolger
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Nichols
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kim Golder
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John S Knight
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Celinski
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Grace Adesina
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Whittington Hospital NHS Trust
City
London
ZIP/Postal Code
N19 5NF
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Southampton University Hospitals NHS Trust
City
Southampton
Country
United Kingdom
12. IPD Sharing Statement
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Cardiopulmonary Exercise Testing and Preoperative Risk Stratification
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