This is a prospective cohort study of patients undergoing surgery for chronic limb threatening ischaemia. Prior to surgery, patients will undergo CardioPulmonary Exercise testing (CPET) using an arm ergometer. Feasibility outcome measures will be recorded at testing and participants will be followed up for a period of up to 5 years to obtain clinical outcome measures.
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. Hypothesis: 1. Cardiopulmonary exercise testing using an arm ergometer (CPETarm) is a feasible, acceptable and safe tool to use at the 'bedside' in patients undergoing emergency surgery for chronic limb threatening ischaemia (CLTI). 2. Values obtained from CPETarm and/or hand grip strength can be used to predict post operative outcomes including major adverse cardiovascular events and mortality for this group of patients. Recruitment: The study will enrol 120 consecutive, eligible and consenting patients admitted with with CLTI to the Manchester Vascular Centre at Manchester University National Health Service Foundation Trust. Patients scheduled to undergo non elective surgical or endovascular treatment of their chronic limb threatening ischaemia will be screened for inclusion. Decision for surgery/management will be recommended by their Consultant Vascular Surgeon.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
CardioPulmonary Exercise Testing using an arm ergometer prior to surgery
University of Manchester
Manchester, Greater Manchester, United Kingdom
Acceptability of bedside CPET
The percentage of recruited participants actually performing CPET compared to the number of patients consenting. (A) identifying reasons, and their number, as to why participants did not undertake CPET, and (B) identifying reasons, and their number, for clinician-led termination of CPET
Time frame: At time of CPET testing (1 day)
Recruitment rate (uptake of bedside CPET)
The percentage of eligible patients who gave informed consent to participate in the study
Time frame: At time of CPET testing (1 day)
Practicality of bedside CPET
Recorded as three variables 1. Time between decision for surgical intervention and CPET testing 2. Location of testing 3. Duration of testing (inclusive of set up, patient instructions, completion of test and recovery)
Time frame: At time of CPET testing (1 day)
Patient reported outcome measures
Established by identifying participant opinions on satisfaction with, and suitability of, CPET for future use. Assessed in a qualitative manner using a semi structured interview with 8 pre determined questions and quantitatively using a 5 point Likert scale for 12 statements, whereby 1='strongly disagree' and 5='strongly agree'.
Time frame: 30 days
Adverse or unexpected events report
Defined as participants experiencing serious adverse events during or after the test. Defined adverse events for CPET as: 1) death during the stress test, 2) external defibrillation or implantable cardioverter-defibrillator discharge, 3) sustained ventricular tachycardia (wide complex tachycardia lasting longer than 30 seconds), 4) myocardial infarction, 5) syncope, 6) administration of advanced cardiac life support medications, 7) referral for direct hospital admission, or 8) referral to emergency department
Time frame: At time of CPET testing (1 day)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peri-operative complications
Defined as defined as any complication that occurred during surgery or within 30 days of surgery. Graded using the Clavien-Dindo classification.
Time frame: Recorded at 30 days
All cause mortality
Defined as death from any cause during the study
Time frame: Recorded at 30 days, 90 days, 1 year, 3 years and 5 years
Amputation-free survival
Freedom of death and major limb amputation during the study
Time frame: Recorded at 30 days, 90 days, 1 year, 3 years and 5 years
Level of care post-surgery
Categorised as according to the ward the patient is cared for in the immediate post operative period. * Level 0 (postoperative recovery on a surgical ward * Level 1 (postoperative recovery on a surgical ward with access to a critical care outreach team) * Level 2 (high dependency unit, post anaesthesia care unit) * Level 3 (intensive care unit)
Time frame: Recorded at 30 days
Higher level of care length of stay
Recorded as the length of stay on a ward categorised as level 2 or 3.
Time frame: Recorded at 30 days
Length of hospital stay
Defined as number of days spent in index hospital from date of operation.
Time frame: Recorded at 30 days
Discharge destination
Recorded as place of discharge from hospital. Discharge destination, dichotomized as home or non-home. Non-home discharge was defined as discharge to a skilled care facility (e.g., a transitional care unit, subacute hospital, or skilled nursing home), unskilled care (e.g., nursing home or assisted facility, only if this was not the patient's preoperative location), separate acute care, rehabilitation, or a multi-level senior community)
Time frame: Recorded at 30 days
Rate of re-intervention
Primary patency: Freedom from occlusion of bypass-graft or endovascular treated arterial segment and freedom of restenosis that need intervention in bypass-graft or endovascular treated arterial segment. Secondary patency: Freedom from occlusion of bypass-graft or endovascular treated arterial segment. Treated for restenosis in bypass-graft or endovascular treated arterial segment.
Time frame: Recorded at 30 day and 90 days
Hospital readmission rate
Defined as a readmission after discharge from the index hospital stay and within 90 days of the primary surgical procedure
Time frame: Recorded at 30 and 90 days.
Health related quality of life
Health related quality of life measured by The Vascular Quality of Life Questionnaire 25 (VASCUQOL25). VascuQol consists of 25 items, subdivided into five domains. Each question has a seven-point response scale. The responses are averaged to give an overall and a domain score ranging from one (worst Health Related Quality of Life, HRQoL) to seven (best HRQoL).
Time frame: Recorded at 30 and 90 days
Major adverse cardiovascular events
Defined as non fatal myocardial infarction, non fatal stroke, cardiovascular death, coronary intervention or unstable angina requiring hospitalisation.
Time frame: Recorded at 30 and 90 days