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

NCT06033677 | Completed

• 1 other identifier: 114-24/06/2022
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Catheterization, Peripheral

Keywords

Invasive arterial pressure monitoring; Distal radial artery cannulation; Fovea radialis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• arterial catheterization time

  during cannulation procedure

• Monitored arterial waveform success

  During the intraoperative period

• Compression time after catheter removal

  procedure (the process until the catheter is removed and the bleeding stops)

• complication follow-up

  Complication follow-up will be done from the beginning of cannulation procedure to the 24th hour postoperatively.

Study Arms (2)

Grup 1-Forearm radial artery cannulation (FRA)

OTHER

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

Grup 2-Distal radial artery cannulation (DRA)

ACTIVE COMPARATOR

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

Interventions

Distal radial artery cannulation PROCEDURE

Interventional application for invasive blood pressure monitoring

Grup 2-Distal radial artery cannulation (DRA)

Forearm radial artery cannulation PROCEDURE

Interventional application for invasive blood pressure monitoring

Grup 1-Forearm radial artery cannulation (FRA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital:

Diyarbakır, 21070, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32321695 BACKGROUND

• 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.

  PMID: 33147107 RESULT

Study Officials

• Meral Edal Erbatur, M.D.

  University of Health Sciences Gazi Yasargil Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and reanimation spesialist

Model Details: Patients scheduled for elective surgery and requiring invasive arterial monitoring were divided into two groups. Group 1: 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. Group 2: 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.

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 13, 2023
• Study Start: January 17, 2024
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)