Surgery-Complications Clinical Trial
Official title:
Novel Use of Bedside Arm Ergometry CardioPulmonary Exercise Tests for the Risk Stratification of Patients With Chronic Limb-threatening Ischaemia: A Feasibility Trial
| Verified date | May 2024 |
| Source | University of Manchester |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 120 |
| Est. completion date | April 28, 2030 |
| Est. primary completion date | May 28, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Ability and willingness to give written informed consent - Diagnosis of chronic limb threatening ischaemia, undergoing one of the following procedures: Infra inguinal bypass, Extra anatomical bypass, Common femoral endarterectomy, Endovascular treatment, Primary amputation Exclusion Criteria: - Patients with active medical conditions deemed an absolute contraindication for undertaking CPET - Ongoing evaluation for coronary artery disease (e.g awaiting stress test or cardiac catheterisation or requiring the up titration of anti anginal medications) - Active arrthymic requiring the initiation or up titration of an anti arrthymic medication - Active congestive cardiac failure requiring the initiation or up titration of diuretic therapy. - Severe cardiac valvular stenosis - Physical disability precluding ability to perform CPETarm - Psychiatric disorder or dementia precluding them from consenting for research and/or undertaking testing and/or follow up |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Manchester | Manchester | Greater Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| University of Manchester |
United Kingdom,
[1] Conte MS, Bradbury AW, Kolh P, et al. GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. Eur J Vasc Endovasc Surg, 2019. 58: p. 1-109.
[2] Waton S, Johal A, Li Q, et al. National Vascular Registry: 2023 State of the Nation Report. London: The Royal College of Surgeons of England, November 2023.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
At time of CPET testing (1 day) | |
| Primary | Recruitment rate (uptake of bedside CPET) | The percentage of eligible patients who gave informed consent to participate in the study | At time of CPET testing (1 day) | |
| Primary | Practicality of bedside CPET | Recorded as three variables
Time between decision for surgical intervention and CPET testing Location of testing Duration of testing (inclusive of set up, patient instructions, completion of test and recovery) |
At time of CPET testing (1 day) | |
| Primary | 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'. |
30 days | |
| Primary | 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 |
At time of CPET testing (1 day) | |
| Secondary | 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. | Recorded at 30 days | |
| Secondary | All cause mortality | Defined as death from any cause during the study | Recorded at 30 days, 90 days, 1 year, 3 years and 5 years | |
| Secondary | Amputation-free survival | Freedom of death and major limb amputation during the study | Recorded at 30 days, 90 days, 1 year, 3 years and 5 years | |
| Secondary | 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) |
Recorded at 30 days | |
| Secondary | Higher level of care length of stay | Recorded as the length of stay on a ward categorised as level 2 or 3. | Recorded at 30 days | |
| Secondary | Length of hospital stay | Defined as number of days spent in index hospital from date of operation. | Recorded at 30 days | |
| Secondary | 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) | Recorded at 30 days | |
| Secondary | 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. |
Recorded at 30 day and 90 days | |
| Secondary | Hospital readmission rate | Defined as a readmission after discharge from the index hospital stay and within 90 days of the primary surgical procedure | Recorded at 30 and 90 days. | |
| Secondary | 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). | Recorded at 30 and 90 days | |
| Secondary | Major adverse cardiovascular events | Defined as non fatal myocardial infarction, non fatal stroke, cardiovascular death, coronary intervention or unstable angina requiring hospitalisation. | Recorded at 30 and 90 days |