Use of CPETarm for Risk Stratification of Patients With CLTI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manchester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
CardioPulmonary Exercise Testing
Diagnostic testCardioPulmonary Exercise Testing using an arm ergometer prior to surgery
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: CardioPulmonary Exercise TestingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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 daysSecondary outcomes
1
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 days2
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 years3
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 years4
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 daysSponsors and contacts
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Source ClinicalTrials.gov
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