Novel Use of Bedside Arm Ergometry CardioPulmonary Exercise Tests for the Risk Stratification of Patients With Chronic Limb-threatening Ischaemia: A Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Acceptability of bedside CPET
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Acceptability of bedside CPET
时间窗: At time of CPET testing (1 day)
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
Recruitment rate (uptake of bedside CPET)
时间窗: At time of CPET testing (1 day)
The percentage of eligible patients who gave informed consent to participate in the study
Adverse or unexpected events report
时间窗: At time of CPET testing (1 day)
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
Practicality of bedside CPET
时间窗: At time of CPET testing (1 day)
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)
Patient reported outcome measures
时间窗: 30 days
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'.
次要结局
- Length of hospital stay(Recorded at 30 days)
- Rate of re-intervention(Recorded at 30 day and 90 days)
- Hospital readmission rate(Recorded at 30 and 90 days.)
- Amputation-free survival(Recorded at 30 days, 90 days, 1 year, 3 years and 5 years)
- Level of care post-surgery(Recorded at 30 days)
- Health related quality of life(Recorded at 30 and 90 days)
- Higher level of care length of stay(Recorded at 30 days)
- Peri-operative complications(Recorded at 30 days)
- All cause mortality(Recorded at 30 days, 90 days, 1 year, 3 years and 5 years)
- Discharge destination(Recorded at 30 days)
- Major adverse cardiovascular events(Recorded at 30 and 90 days)
研究者
Jonathan Ghosh
Honorary Reader Cardiovascular Sciences, Consultant and Clinical Director
University of Manchester