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临床试验/NCT06433960
NCT06433960已完成不适用

A Cross-Sectional Study and a Novel Screening Survey for Radial Artery Assessment in Surgical Coronary Revascularisation

Papworth Hospital NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2024年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
2
主要终点
Sensitivity of Radial Artery Assessment Techniques

研究概览

简要总结

The goal of this observational study is to learn about how screening tests inform the radial artery (RA) suitability for harvesting and coronary bypass grafting in adults with ischaemic heart disease. The main question it aims to answer is:

• What factors influence the diagnostic accuracy of RA screening in patients undergoing surgical coronary revascularisation?

Participants will:

  • Receive an assessment of their RA through routinely used techniques (Modified Allen Test +/- pulse-oximetry, Barbeau Test and Ultrasound examination)
  • Answer a symptoms scale about their physical experience after surgery

详细描述

A multi-centre cross-sectional study design to investigate the validity of radial artery (RA) assessment techniques in adults with ischaemic heart disease undergoing surgical coronary revascularisation with their RA being selected as an autologous graft conduit.

Patients taking part in the study will receive an assessment of the arterial forearm circulation from their non-dominant upper extremity through multiple observations.

Pre-operative observations. Before surgery (in the ward environment after the patient is being admitted or whilst patient in the anaesthetic room) the forearm blood circulation is measured through a Modified Allen Test (MAT) (+/- pulse-oximetry), Barbeau Test and Ultrasonography examination. Assessment will be performed by experienced Surgical Care Practitioners/Advanced Nurse Practitioners/Cardiac Specialist Registrars. These assessments will inform the decision to surgically expose the RA.

Intra-operative observations. Oxygen saturation readings are taken prior to harvest the RA. Once the RA is surgically harvested a series of measures are taken through a validated structured questionnaire: the Radial Artery Quality Evaluation Survey (RAQES).

Observations at 4-6 weeks post operation. Patients finger movements, cold tolerance sensitivity and tactile/touch perception is measured through an ordinal symptoms scale (Follow-up Radial Artery Harvesting Scale) at post-operative day 2-5 and at follow-up appointment (3-6 weeks after surgery). Bilateral comparison between hands and forearms will be undertaken. A Surgical Care Practitioner will perform this assessment post-operatively.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female adults patients undergoing elective or urgent coronary artery bypass graft (CABG) surgery and radial artery (RA) harvesting in two Cardiothoracic hospitals.

排除标准

  • Paediatric patients and/or adult patients undergoing emergency CABG will not be considered within the participants of this cross-sectional study, as well as patients lacking capacity to consent and non-English speaking patients requiring use of interpreters. Patients not wishing to participate in the study will also not be recruited.

结局指标

主要结局

Sensitivity of Radial Artery Assessment Techniques

时间窗: From enrollment to the end of treatment at 12 weeks.

Measure the sensitivity of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.

Specificity of Radial Artery Assessment Techniques

时间窗: From enrollment to the end of treatment at 12 weeks.

Measure the specificity of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.

Negative and Positive predictive values of Radial Artery Assessment Techniques

时间窗: From enrollment to the end of treatment at 12 weeks.

Measure the negative and positive predictive values of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.

次要结局

  • Radial Artery Quality Evaluation(From enrollment to surgical harvesting of the radial artery at day 1-2 after hospitalisation.)
  • Patients Physical Experience Evaluation(From day of surgery to the end of treatment at 12 weeks.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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