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

Catheterization, Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04001764
• Other study ID #: direnctez
• Status: Completed
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: December 2019
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In patients requiring frequent arterial blood gas sampling in the intensive care unit and in cases requiring continuous blood pressure monitoring, arterial cannulation is preferred. The use of USG has also become widespread in anesthesia practice. It is supported by studies that USG-guided interventions cause fewer complications compared to classical methods and reduce intervention time. USG-guided arterial catheterization method is based on the principle of direct visualization of the artery and catheter via USG. In this technique, the catheter and the needle tip are displayed simultaneously with the USG guided to the artery lumen. Imaging of anatomical structures with USG has resulted in a reduction of complications and shortening of the processing time. In the USG screen, adjacent anatomical formations such as veins and nerve structures are simultaneously displayed. This reduces the risk of complications.

Two different techniques are used for USG mediated radial artery cannulation. The first one is the in-plane technique, which forms the long axis image of the arteries by positioning the USG probe to parallel to the vein, and the second is the out-of-plane technique, which forms a short axis image with the probe positioned perpendicular to the arteries.

The ideal location of radial artery catheterization with USG or the advantages/disadvantages of the catheterization zone are not available.

In this randomized prospective and open-label study, patients will be divided into three groups. 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. Comparison of these three groups, in terms of duration of use of arterial cannula, initial entry success rates, duration of intervention, number of procedures used, number of cannulas used and effects on early and late complications, and advantages if any is intended.

Patients will be randomly distributed to three groups. Diagnosis, age, sex, height, weight, and body mass index of the patients will be recorded. The random distribution of obese patients to groups will be ensured. Allen test will be done to the patients before the intervention. Radial artery catheterization will be applied only to patients with the collateral flow. Each group will be measured and recorded before, during and after the intervention. Before the intervention, local anesthetic infiltration will be applied and asepsis will be provided. Early complications (such as hematoma, hemorrhage) and late complications (such as circulatory disorders) will be observed and recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: October 1, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)]

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• The radial artery cannulation over 2 cm of the wrist
The radial artery catheterization performed as short axis out-of-plane with USG over 2 cm of the wrist.
• The radial artery cannulation in the distal 3/4 area of the forearm
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 radial artery cannulation in the distal 1/2 area of the forearm
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.

Locations

Country	Name	City	State
Turkey	Izmir Bozyaka Training and Research Hospital	Izmir	Karabaglar

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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):163-9. doi: 10.1213/ANE.0000000000000242. — View Citation

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. Epub 2006 Nov 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Use of Arterial Cannula	From the time arterial cannula is successfully inserted until cannula cannot use	During Procedure
Secondary	Initial Entry Success Rates	Success or fail of initial entry	During procedure
Secondary	Duration of Intervention	Time from the beginning of procedure and successful cannulation of radial artery	During procedure
Secondary	Number of Punctures	Count of punctures until successful artery cannulation	During procedure
Secondary	Early Complications	Complications seen during procedure	During procedure
Secondary	Late Complications	Complications seen after successful completion of artery cannulation	Up to 7 days