Cardiopulmonary Exercise Testing and Preoperative Risk Stratification (CPX or CPEX)
Recruitment status was Recruiting
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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. As a secondary goal we would also like to assess whether a pre-operative blood test of a heart hormone called B type natriuretic peptide (BNP) can predict heart damage after major surgery.
| Condition | Intervention |
|---|---|
|
Colorectal Surgery Critical Illness |
Other: Perioperative care pathway guided by CPX results Other: Clinician guided care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- Postoperative morbidity (presence or absence of POMS defined morbidity) [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
- Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
- Total postoperative ITU bed utilisation [ Time Frame: End of hospital stay i.e. day of hospital discharge ] [ Designated as safety issue: No ]
- Total postoperative bed utilisation [ Time Frame: End of hospital stay i.e. day of hospital discharge ] [ Designated as safety issue: No ]
- ITU re-admission [ Time Frame: End of hospital stay i.e. day of hospital discharge ] [ Designated as safety issue: No ]
- Death [ Time Frame: Should death occur ] [ Designated as safety issue: No ]
- SF36 (compared with SF36 at baseline) [ Time Frame: 12 months post day of surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 228 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Control - Standard Perioperative Pathway
|
Other: Clinician guided care
Best current practice for choosing postoperative care environment
|
|
Experimental: B
Intervention - Perioperative care pathway guided by CPX Results i.e.anaerobic threshold & ventilatory equivalents
|
Other: Perioperative care pathway guided by CPX results
|
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.
As a secondary goal we would also like to assess whether a pre-operative blood test of a heart hormone called B type natriuretic peptide (BNP) can predict heart damage after major surgery.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Michael PW Grocott | +44 207 288 3887 | mike.grocott@ucl.ac.uk |
| Contact: Paula M Meale | +44 207 288 3887 | rmhapmm@ucl.ac.uk |
| United Kingdom | |
| University College London Hospitals NHS Foundation Trust | Not yet recruiting |
| London, United Kingdom, NW1 2BU | |
| Contact: Jim Down +44 7980079588 jim.down@uclh.nhs.uk | |
| Contact: Paula Meale +44 207 288 3887 rmhapmm@ucl.ac.uk | |
| Whittington Hospital NHS Trust | Recruiting |
| London, United Kingdom, N19 5NF | |
| Contact: Martin B Kuper +44 207 288 3887 martin.kuper@whittington.nhs.uk | |
| Contact: Paula M Meale +44 207 288 3887 rmhapmm@ucl.ac.uk | |
| 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: | James Pate | 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: | Zoe Broadhead | UCLH |
| Principal Investigator: | Carmel Young | UCLH |
More Information
No publications provided
| Responsible Party: | Patricia Martinez (Sponsors Representative), University College London |
| ClinicalTrials.gov Identifier: | NCT00737828 History of Changes |
| Other Study ID Numbers: | 07/0114, NHNN REC NO: 07/H0716/55, NIHR: PB-PG-0906-11426 |
| Study First Received: | August 18, 2008 |
| Last Updated: | July 13, 2010 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University College London Hospitals:
|
Cardiopulmonary exercise test CPX CPEX |
surgical outcome colorectal surgery risk stratification |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013