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
Sponsor study identifier
Secondary identifiers
OTHER · NHNN REC Number
OTHER_GRANT · UK National Institute of Health Research (NIHR)
interventional
228
1 country
3
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
May 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 18, 2008
Actual (reported)August 20, 2008
Actual (reported)June 2013
Actual (reported)May 2014
Actual (reported)Postoperative morbidity (presence or absence of POMS defined morbidity)
Day 5
Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary
Day 5
Total postoperative ITU bed utilisation
End of hospital stay i.e. day of hospital discharge
Total postoperative bed utilisation
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
* 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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Whittington Hospital NHS Trust
London, N19 5NF, United Kingdom
University College London Hospitals NHS Foundation Trust
London, NW1 2BU, United Kingdom
Southampton University Hospitals NHS Trust
Southampton, United Kingdom
Michael PW Grocott
University College, London
Paula Meale
University College, London
Michael Mythen
University College, London
Ayo Oshowo
Whittington Hospital NHS Trust
228 participants (actual enrollment reported by the registry).
First Submitted
August 18, 2008
First Posted
August 20, 2008
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
End of hospital stay i.e. day of hospital discharge
ITU re-admission
End of hospital stay i.e. day of hospital discharge
Death
Should death occur
Contact the study team to confirm eligibility.
Mervyn Singer
University College, London
Geoff Bellingan
University College London Hospitals
Kay Mitchell
University College, London
Hasan Muktar
The Whittington Hospital Hospital NHS Trust
Alistair Windsor
University College London Hospitals
Jim Down
University College London Hospitals
Martin B Kuper
Whittington Hospital NHS Trust
Denny ZH Levett
University College, London
Phil Hennis, PhD
UCL
Alasdair O'Doherty, MSc
UCL
Alec Engledow
University College London Hospitals
Aundrea Mulreany
Whittington Hospital
Carolyn Dr Way
University Hospital Southampton NHS Foundation Trust
Karen Linford
University Hospital Southampton NHS Foundation Trust
Clare Bolger
University Hospital Southampton NHS Foundation Trust
Paul Nichols
University Hospital Southampton NHS Foundation Trust
Kim Golder
University Hospital Southampton NHS Foundation Trust
John S Knight
University Hospital Southampton NHS Foundation Trust
Michael Celinski
University Hospital Southampton NHS Foundation Trust
Grace Adesina
University College London Hospitals
Primary Completion
June 2013
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
May 21, 2014
Record last verified: 2014-05
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Source: ClinicalTrials.gov.
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