Use of CPETarm for risk stratification of patients with CLTI.Version 2

  • Research type

    Research Study

  • Full title

    Novel use of bedside arm ergometry CardioPulmonary Exercise Tests for the risk stratification of patients with chronic limb-threatening ischaemia: A Feasibility Trial

  • IRAS ID

    329960

  • Contact name

    Jonathan Ghosh

  • Contact email

    jonathan.ghosh@manchester.ac.uk

  • Sponsor organisation

    University of Manchester

  • Duration of Study in the UK

    6 years, 0 months, 0 days

  • Research summary

    Chronic limb-threatening ischaemia (CLTI) is the most severe clinical manifestation of peripheral arterial disease, defined by the presence of pain at rest and/or tissue loss affecting the legs. It is a major cause of chronic pain, amputation and death. CLTI is a growing global healthcare problem attributable to the ageing population and increase of risk factors such such as diabetes.

    Prevalence of high blood pressure, heart disease and diabetes is high amongst this cohort of patients and so it is unsurprising that surgery is associated with an alarmingly high risk of illness, complications and even death when compared to other types of surgery. As nearly half of the patients present as an emergency, assessment and optimisation of health prior to surgery is challenging.

    The aims of the assessment prior to surgery includes optimising any current health problems, understanding what care may be required after surgery, allowing the patient to be fully informed of the risks and considering non surgical options where appropriate. Inadequate risk stratification can lead to delays in theatre, increased length of hospital stay and unnecessary loss of limb and/or life.

    Currently there is no established method to risk stratify CLTI patients presenting as an emergency. CardioPulmonary Exercise Testing (CPET) is an exercise test useful in identification of a number of heart and lung conditions. The test is established for risk-stratification in other populations but its method of using a bicycle is not suitable for CLTI patients, nor has it previously been used in the emergency setting. This study will assess whether CPET using arm exercise instead of the traditional bicycle is a feasible test that can be performed at the bedside within 48 hours of intention to treat, required to make it a practical test in the assessment of emergency patients.

  • REC name

    North West - Greater Manchester South Research Ethics Committee

  • REC reference

    24/NW/0007

  • Date of REC Opinion

    15 Feb 2024

  • REC opinion

    Further Information Favourable Opinion