Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients

NCT04001764 | Completed

• 1 other identifier: direnctez
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Whether there is a difference in the duration of use of arterial cannula, first entry success rates, duration of intervention, number of procedures, the number of cannulas used and the effects on early and late complications and advantages between the groups will be investigated.

Conditions

Arterial Cannulation in Intensive Care Unit; Catheterization, Peripheral; Radial Artery

Keywords

Arterial Catheterization; Peripheral Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Duration of Use of Arterial Cannula

  From the time arterial cannula is successfully inserted until cannula cannot use

  During Procedure

Secondary Outcomes (5)

• Initial Entry Success Rates

  During procedure

• Duration of Intervention

  During procedure

• Number of Punctures

  During procedure

• Early Complications

  During procedure

• Late Complications

  Up to 7 days

Study Arms (3)

The first group

ACTIVE COMPARATOR

The radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group.

Procedure: The radial artery cannulation over 2 cm of the wrist

The second group

EXPERIMENTAL

The radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention.

Procedure: The radial artery cannulation in the distal 3/4 area of the forearm

The third group

EXPERIMENTAL

The radial artery catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane intervention.

Procedure: The radial artery cannulation in the distal 1/2 area of the forearm

Interventions

The radial artery cannulation over 2 cm of the wrist PROCEDURE

The radial artery catheterization performed as short axis out-of-plane with USG over 2 cm of the wrist.

The first group

The radial artery cannulation in the distal 3/4 area of the forearm PROCEDURE

The radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention.

The second group

The radial artery cannulation in the distal 1/2 area of the forearm PROCEDURE

The radial artery catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane intervention.

The third group

Eligibility Criteria

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

You may qualify if:

• Admission of the first degree relatives of the patients and if the patient can give consent
• Patients over 18
• Non-pregnant patients
• Patients without inotropic/vasopressor support
• Patients who do not have contraindications for radial artery cannulation (thrombosis in the distal region, a focus of infection at the site of entry, lack of adequate collateral flow in the Allen test, peripheral vascular diseases \[eg, Raynaud's disease)\]

You may not qualify if:

• Patient/Patient's first degree relatives refuse to work
• Patients under 18
• Pregnant patients
• Patients with contraindications for radial artery cannulation (thrombosis in the distal region, a focus of infection at the site of entry, lack of adequate collateral flow in the Allen test, peripheral vascular diseases \[eg, Raynaud's disease)\]
• Patient's inotropic/vasopressor support

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, Karabaglar, 35170, Turkey (Türkiye)

Location

Related Publications (5)

• Hansen MA, Juhl-Olsen P, Thorn S, Frederiksen CA, Sloth E. Ultrasonography-guided radial artery catheterization is superior compared with the traditional palpation technique: a prospective, randomized, blinded, crossover study. Acta Anaesthesiol Scand. 2014 Apr;58(4):446-52. doi: 10.1111/aas.12299. Epub 2014 Mar 3.

  PMID: 24588456 BACKGROUND

• Quan Z, Tian M, Chi P, Cao Y, Li X, Peng K. Modified short-axis out-of-plane ultrasound versus conventional long-axis in-plane ultrasound to guide radial artery cannulation: a randomized controlled trial. Anesth Analg. 2014 Jul;119(1):163-169. doi: 10.1213/ANE.0000000000000242.

  PMID: 24806143 BACKGROUND

• Levin PD, Sheinin O, Gozal Y. Use of ultrasound guidance in the insertion of radial artery catheters. Crit Care Med. 2003 Feb;31(2):481-4. doi: 10.1097/01.CCM.0000050452.17304.2F.

  PMID: 12576955 BACKGROUND

• Shiver S, Blaivas M, Lyon M. A prospective comparison of ultrasound-guided and blindly placed radial arterial catheters. Acad Emerg Med. 2006 Dec;13(12):1275-9. doi: 10.1197/j.aem.2006.07.015. Epub 2006 Nov 1.

  PMID: 17079789 BACKGROUND

• Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.

  PMID: 34637140 DERIVED

Study Officials

• Zeki T. TEKGUL, Assoc. Prof.

  Izmir Bozyaka Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: June 28, 2019
• Study Start: July 30, 2019
• Primary Completion: September 10, 2019
• Study Completion: October 1, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

TU (1)