The Effect of the Use of Washing Solutions at Different Temperatures Used in Intra-arterial Cannulation

Investigation of the Effect of Washing Solutions at Different Temperatures Used in Intra-arterial Cannulation for Invasive Blood Pressure Measurement by Doppler Ultrasonography

Nowadays, intraarterial catheterization is frequently used as an invasive method for intraoperative blood pressure monitoring and control.The radial artery is frequently used in this procedure and the cannula should be flushed with 2-3 ml of heparinized fluid intermittently to prevent occlusion. During the operation, the ambient temperature is approximately 22-24 C and the patient temperature can be 34-36 C. Since the flushing fluids are also in the environment, they are 22-24 C. The aim of this study is to determine whether the fluids at room temperature cause vasoconstriction in the vessel and cause a change in blood pressure arterial values.

Study Overview

• Status: Not yet recruiting
• Conditions: Intrarterial Catheterization
• Intervention / Treatment: Other: intra-arterial flushing; Other: intra-arterial flushing

Detailed Description

The aim of this study is to determine whether room temperature fluids cause vasoconstriction or vasodilatation in the vessel and cause a change in blood pressure arterial values.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Korgün Ökmen, Assoc. PhD.; Phone Number: +905057081021; Email: korgunokmen@gmail.com

Study Locations

• Turkey
  • Bursa, Turkey, 16110
    • Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• ASA I-III risk class,
• Medically undergoing intra-arterial cannulation
• Being between the ages of 18-70

Exclusion Criteria:

• Diagnosis of DM
• Vascular disease,
• Bleeding diathesis,
• inotropic drug use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: room temperature washing solution; İntra-arterial flushing with heparinized fluid kept in room air	Other: intra-arterial flushing; The catheter will be flushed to prevent occlusion after radial artery catheterization. intra-arterial flushing with heparinized fluid kept in room air; Other Names: group room; Other: intra-arterial flushing; Intra-arterial flushing with heparinized fluid at patient body temperature; Other Names: group patient
Active Comparator: washing solution at patient temperature; Intra-arterial flushing with heparinized fluid at patient body temperature	Other: intra-arterial flushing; The catheter will be flushed to prevent occlusion after radial artery catheterization. intra-arterial flushing with heparinized fluid kept in room air; Other Names: group room; Other: intra-arterial flushing; Intra-arterial flushing with heparinized fluid at patient body temperature; Other Names: group patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial flow velocities PSV	After flushing performed , peak systolic velocity (PSV) values in the radial artery by Ultrasound doppler method.	30th seconds after arterial flush
Arterial flow velocities End-diastolic velocity	After flushing performed , end- diastolic velocity (EDV) values in the radial artery by ultrasound doppler method;	30th seconds after arterial flush
Arterial flow velocities resistive indices	After flushing performed resistive indices (RI) values in the radial artery by ultrasound doppler method.	30th seconds after arterial flush

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
invasive and non-invasive blood pressure	After flushing performed systolic, diastolic, and average blood pressure values measured	10th,30th,60th,90th ,120th and 150th seconds

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 16, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): January 15, 2024

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 10, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023/06-1

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