Radial Artery Assessment in Surgical Coronary Revascularisation

Recruiting

• Conditions: Coronary Artery Disease; Coronary Artery Bypass Grafting
• Interventions: Diagnostic Test: Modified Allen Test; Diagnostic Test: Pulse-oximetry guided Modified Allen Test; Diagnostic Test: Barbeau Test; Diagnostic Test: Ultrasound examination of the forearm arteries; Diagnostic Test: Measurement of oxygen saturation; Other: Radial Artery Quality Evaluation Survey; Other: Follow-up Radial Artery Harvesting Scale

• Registration Number: NCT06433960
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

Brief Summary

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

Detailed Description

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.

Consecutive sampling will be used for the recruitment of study participants. The minimum required number of participants to test and verify research hypotheses is sixty-nine patients (N=69). An adaptive trial design will be implemented: at quarterly assessment points the statistical power is assessed and the remaining sample size required is updated accordingly.

Sample size calculation was undertaken using G\*Power software (version 3.1) using Chi-squared Test and adopting optimal effect size (w=0.4) and power (0.8).

Descriptive and inferential statistics will be used to perform quantitative analyses. Descriptive statistics (mode, median) will be implemented to analyse RAQES answers and ordinal symptoms scale findings and cross-tabulation used to record relationship between variables. Data analysis will also include measurement of sensitivity, specificity, positive and negative predictive values to investigate the validity of the RA assessment techniques. Correlational analysis will be implemented and Receiver Operating Characteristic curve analysis will be used to compare the diagnostic accuracy of the MAT, pulse-oximetry guided MAT and Barbeau Test with the ultrasonography examination.

Study Timeline

• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-30
• Status Verified: 2024-07
• Study Start: 2024-07-10
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiovascular sample group	Ultrasound examination of the forearm arteries	Cardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals.
Cardiovascular sample group	Measurement of oxygen saturation	Cardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals.
Cardiovascular sample group	Follow-up Radial Artery Harvesting Scale	Cardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals.
Cardiovascular sample group	Pulse-oximetry guided Modified Allen Test	Cardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals.
Cardiovascular sample group	Modified Allen Test	Cardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals.
Cardiovascular sample group	Barbeau Test	Cardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals.
Cardiovascular sample group	Radial Artery Quality Evaluation Survey	Cardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals.

Primary Outcome Measures

Name	Time	Method
Sensitivity of Radial Artery Assessment Techniques	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Radial Artery Quality Evaluation	From enrollment to surgical harvesting of the radial artery at day 1-2 after hospitalisation.	Measure the morphological and physiological quality of radial arteries through a validated structured questionnaire (Radial Artery Quality Evaluation Survey)
Patients Physical Experience Evaluation	From day of surgery to the end of treatment at 12 weeks.	Measure the patients' finger movements, cold tolerance sensitivity and tactile/touch perception through an ordinal symptoms scale (Follow-up Radial Artery Harvesting Scale).

Trial Locations

Locations (2)

Royal Papworth Hospital; 🇬🇧 Cambridge, England/Cambridgeshire, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, England, United Kingdom