Increasing Security With End-zone Arterial Blood Pressure Monitoring During Surgery

"Intraoperative Use of Distal Radial Artery Cannulation With Snuffbox Approach'

Short summary: The aim of this randomized controlled clinical research study was to compare distal radial artery cannulation with forearm radial artery cannulation in terms of efficacy and ease of administration. The investigators believe that cannulation of the distal radial artery in cases requiring invasive arterial monitoring should preserve the radial artery of the forearm for future health problems and reduce circulatory complications by working more distally.

The main question[s] aims to answer are:

• [question 1]: whether artery monitoring can be performed with a more distal approach
• [question 2]: efficacy and safety of the distal approach

Study Overview

• Status: Recruiting
• Conditions: Catheterization, Peripheral
• Intervention / Treatment: Procedure: Forearm radial artery cannulation; Procedure: Distal radial artery cannulation

Detailed Description

The distal radial artery (dRA) in the snuffbox location is a popular arterial access site for interventional cardiological procedures and neurointerventions. The investigators aimed to investigate the distal radial artery as an alternative site to the classical radial artery (RA) in cases requiring intraoperative arterial cannulation and blood pressure monitoring. The superficial location of the classic radial artery, its collateral blood flow with the ulnar artery, and limited complications make it a preferred choice for catheterization purposes. Given its use in various medical procedures such as flap transplantation, creating arteriovenous fistulas for hemodialysis, and bypass grafting, the investigators believe that preserving the classic radial artery is essential for potential health issues likely to arise in the future. In addition, the investigators aim to minimize circulatory complications by working more distally. Furthermore, it's worth mentioning that alterations in wrist positioning causing disruptions in the invasive arterial waveform also create a need for a different puncture approach. For all these conditions, the investigators believe that the snuffbox approach to distal radial artery cannulation would be an advantageous alternative.

This study will be a prospective randomized, controlled single-blind study. Patients who are scheduled for elective surgery, aged 18 and above, with ASA 1, 2, or 3 classifications, and requiring intraoperative arterial cannulation at Diyarbakır Gazi Yaşargil Training and Research Hospital will be included in the study. The exclusion criteria for participating in the study are as follows: under 18 years of age, ASA-4 classification, presence of non-palpable arteries, presence of burns or infection at the cannulation site, peripheral vascular disease, bleeding or coagulation disorders, negative modified Allen's test, and communication disorders. The withdrawal criteria for the study include a patient's desire to withdraw from the study at any stage and an extended cannulation time.

Participants will be divided into two groups, and ultrasound-guided cannulation will be performed for each group. One group will be cannulated through the classical radial artery of the forearm, while the other group will be cannulated through the distal radial artery using the snuffbox approach. Demographic data (age, gender, weight, height, BMI, comorbidity, medications, ASA, previous artery intervention, working position and working time), USG measurement data (diameter and depth of the artery) and procedural data (hand selection, first attempt success rate, arterial catheterization time, arterial posterior wall puncture rate, intraoperative artery waveform quality, postoperative compression time, and complications) will be recorded.

The sample size was determined by G-Power version 3.1.9.4, taking into account a two-tailed alpha error of 0.05, a power of 0.80, and an effect size of 0.5. Based on this savings and N2/N1 allocations of 0.98 in a previous study ( Distal radial artery as an alternative approach to forearm radial artery for perioperative blood pressure monitoring: a randomized, controlled, noninferiority trial Jingwei Xiong1 , Kangli Hui1 , Miaomiao Xu1 , Jiejie Zhou1 , Jie Zhang1 and Manlin Duan1,2* Xiong et al. BMC Anesthesiology (2022) 22:67 https://doi.org/10.1186/s12871-022-01609-5 ), the minimum number required for the study was planned to be 52 patients in the dRA group and 50 patients in the RA group.

The intervention will be performed under USG guidance by a single anesthesiologist with at least 5 years of experience in arterial cannulation.

The anticipated study duration is 6 months, and once approved by your institution, the study will commence and will be concluded upon reaching the target number of participants.

SPSS 21.0 for Windows software (SPSS Inc., Chicago, IL, USA) will be conducted for statistical analysis of the data. When evaluating the data statistically, numerical data will be expressed as mean and standard deviation, while categorical data will be presented as frequency and percentage. The chi-square test and Fisher's Exact test will be used to compare categorical data between groups, and the results will be reported as percentages (%n). Non-categorical data's normal distribution will be assessed using the Kolmogorov-Smirnov test. For normally distributed data, Student's t-test was used for statistical comparison between groups. For non-normally distributed data, the Mann-Whitney U test was employed. In all analyses, p-values less than 0.05 will be considered statistically significant.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Osman Uzundere, M.D.; Phone Number: +905330206362; Email: osmanuzundere@gmail.com
• Study Contact Backup: Name: Meral erdal erbatur, M.D.; Phone Number: +905056960814; Email: merdalerbatur@gmail.com

Study Locations

• Turkey
  • Diyarbakır, Turkey, 21070
    • Recruiting
    • Health Sciences University Gazi Yaşargil Training and Research Hospital:
    • Contact: Meral erdal erbatur, M.D.; Phone Number: +905056960814; Email: merdalerbatur@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who are scheduled for elective surgery
• Aged 18 and above
• ASA 1, 2, or 3 classifications
• Requiring intraoperative arterial cannulation
• At TC SBÜ Diyarbakır Gazi Yaşargil Training and Research Hospital will be included in the study

Exclusion Criteria:

• Under 18 years of age
• ASA-4 classification
• Presence of non-palpable arteries
• Presence of burns or infection at the cannulation site
• Peripheral vascular disease, bleeding or coagulation disorders
• Negative modified Allen's test, and communication disorders. The withdrawal criteria for the study include a patient's desire to withdraw from the study at any stage and an extended cannulation time.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Grup 1-Forearm radial artery cannulation (FRA); The patients who were to undergo forearm radial artery catheterization were positioned with wrist dorsifection up to 30° and forearm supination. Intervention was planned after ultrasonographic measurements were taken.	Procedure: Forearm radial artery cannulation; Interventional application for invasive blood pressure monitoring
Active Comparator: Grup 2-Distal radial artery cannulation (DRA); The patients who will undergo distal radial artery catheterization were placed in the pronation position of the forearm with the anatomical snuffbox facing upwards. Intervention was planned after ultrasonographic measurements were taken.	Procedure: Distal radial artery cannulation; Interventional application for invasive blood pressure monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of interventions performed with USG guidance	The number of attempts will be recorded as 1st attempt, 2nd attempt and 3rd and above attempts.	during cannulation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial catheterization time	Arterial catheterization time will be evaluated as under or over 3 minutes.	during cannulation procedure
Monitored arterial waveform success	Monitored arterial waveform success will be evaluated as follows; successful (there is a wave); fail (no wave); intraoperative damping time (the time during which the arterial wave disappears while the operation continues)	During the intraoperative period
Compression time after catheter removal	After the catheter is removed, the compression time will be measured in seconds. Bleeding will be checked every 30 seconds.	procedure (the process until the catheter is removed and the bleeding stops)
complication follow-up	Developing complications (vasospasm, hematoma, color and temperature change in the finger); During the intraoperative period,; In the postoperative periodupon first arrival in the recovery room,1st hour at the end of the operation,6th hour at the end of the operation and24st at the end of the operation] will be recorded.	Complication follow-up will be done from the beginning of cannulation procedure to the 24th hour postoperatively.

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Publications and helpful links

General Publications

• Hamandi M, Saad M, Hasan R, Megaly M, Abbott JD, Dib C, Szerlip M, Potluri S, Lotfi A, Kiemeneij F, Al-Azizi KM. Distal Versus Conventional Transradial Artery Access for Coronary Angiography and Intervention: A Meta-Analysis. Cardiovasc Revasc Med. 2020 Oct;21(10):1209-1213. doi: 10.1016/j.carrev.2020.03.020. Epub 2020 Mar 14.
• Hammami R, Zouari F, Ben Abdessalem MA, Sassi A, Ellouze T, Bahloul A, Mallek S, Triki F, Mahdhaoui A, Jeridi G, Abid L, Charfeddine S, Kammoun S, Jdidi J. Distal radial approach versus conventional radial approach: a comparative study of feasibility and safety. Libyan J Med. 2021 Dec;16(1):1830600. doi: 10.1080/19932820.2020.1830600.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): March 17, 2024
• Study Completion (Estimated): March 18, 2024

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Invasive arterial pressure monitoring; Distal radial artery cannulation; Fovea radialis
• Other Study ID Numbers: 114-24/06/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No