Radial Artery Assessment in Surgical Coronary Revascularisation

CompletedOBSERVATIONAL
Enrollment

77

Participants

Timeline

Start Date

July 10, 2024

Primary Completion Date

January 8, 2025

Study Completion Date

March 31, 2025

Conditions
Coronary Artery Bypass GraftingCoronary Artery Disease
Interventions
DIAGNOSTIC_TEST

Modified Allen Test

"Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 1 minute.~Instruct the patient to clench their wrist while the examiner occlude with three fingers the patients ulnar and radial arteries; instruct the patient to unclench their wrist; release the ulnar artery. The MAT result is negative or positive considering in how long the palm flushes:~≤5 seconds: negative MAT; good collateral hand circulation (suggesting harvestable radial artery).~greater than 5 seconds: positive MAT; poor collateral hand circulation (suggesting not-harvestable radial artery)."

DIAGNOSTIC_TEST

Pulse-oximetry guided Modified Allen Test

"Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 1 minute.~A pulse-oximetry probe is positioned on the patients index finger; both radial and ulnar arteries are occluded by the examiner (with three fingers) until flattening of pulse waveform is obtained. Pressure on the ulnar artery is released and the result of the assessment is calculated considering in how long the pulse waveform returns to baseline:~≤5 seconds: negative result (suggesting harvestable radial artery). greater than 5 seconds: positive result (suggesting not harvestable radial artery).~(Busti and Kellogg, 2015)"

DIAGNOSTIC_TEST

Barbeau Test

"Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 2 minutes.~A pulse-oximetry probe is positioned on the patients thumb; the radial artery is then compressed by the examiner, and the pulse waveform is analysed for up to 120 seconds, providing four result patterns of ulno-palmar patency:~1. No damping of the pulse tracing immediately after compression (suggesting harvestable radial artery)~2. Damping of the pulse tracing (suggesting harvestable radial artery)~3. Loss of the pulse tracing, followed by recovery within 120 sec (suggesting harvestable radial artery)~4. Loss of the pulse tracing, without recovery within 120 sec (suggesting not harvestable radial artery).~(Zalocar et al., 2020)"

DIAGNOSTIC_TEST

Ultrasound examination of the forearm arteries

"Pre-operative intervention aimed at evaluating morphological characteristics (diameter, presence of calcifications) of the radial and ulnar arteries. Duration: 5 minutes.~The radial artery is surgically exposed (negative result) when the following apply:~1. ulnar artery inner diameter ≥2 mm~2. radial artery inner diameter ≥2 mm~3. absence of radial artery intraluminal calcifications and plaques.~(Vukovic et al., 2017)"

DIAGNOSTIC_TEST

Measurement of oxygen saturation

"Intra-operative intervention aimed at evaluating the blood oxygen level in the hand if the radial artery was harvested. Duration: 1 minute.~The radial artery is surgically harvested when the oxygen saturation reading (SpO2) from the thumb through pulse-oximetry remains at 95% or above when an occlusive atraumatic clamp is applied on the mobilised radial artery."

OTHER

Radial Artery Quality Evaluation Survey

"Intra-operative intervention (validated structured questionnaire) aimed at evaluating anatomical and physiological characteristics of the radial artery and suitability for coronary graft implantation.~The radial artery is surgically harvested when its morphology and pathology (diameter, calcifications, presence of pulsatile flow), quality of harvesting technique and surgical accessibility are considered satisfactory, good or optimal.~The Radial Artery Quality Evaluation Survey is completed by surgical care practitioners."

OTHER

Follow-up Radial Artery Harvesting Scale

"Postoperative intervention (ordinal symptoms scale) aimed at evaluating patients finger movements, cold tolerance sensitivity and tactile/touch perception at post-operative day 2 to 5 and at follow-up appointment (3-6 weeks after surgery). Bilateral comparison between hands and forearms is undertaken. Tactile perception is assessed through monofilaments (single touch). Cold sensitivity is assessed through the use of ice-pack.~The Follow-up Radial Artery Harvesting Scale was developed from a verbal rating scale (VRS) questionnaire documented in the literature. The VRS questionnaire was re-adapted to appreciate people postoperative experience with their finger movements, cold sensitivity and tactile/touch perception of their forearm."

Trial Locations (2)

SW3 6NP

Royal Brompton Hospital, London

CB20AY

Royal Papworth Hospital, Cambridge

All Listed Sponsors
lead

Papworth Hospital NHS Foundation Trust

OTHER_GOV

NCT06433960 - Radial Artery Assessment in Surgical Coronary Revascularisation | Biotech Hunter | Biotech Hunter