Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433960
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-23
Brief Title:
Radial Artery Assessment in Surgical Coronary Revascularisation
Sponsor:
Papworth Hospital NHS Foundation Trust
Organization:
Papworth Hospital NHS Foundation Trust
Study Overview
Official Title:
A Cross-Sectional Study and a Novel Screening Survey for Radial Artery Assessment in Surgical Coronary Revascularisation
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 PractitionersAdvanced Nurse PractitionersCardiac 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 tactiletouch 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 N69 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 GPower software version 31 using Chi-squared Test and adopting optimal effect size w04 and power 08
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
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 PractitionersAdvanced Nurse PractitionersCardiac 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 tactiletouch 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 N69 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 GPower software version 31 using Chi-squared Test and adopting optimal effect size w04 and power 08
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None