Local Warming Technique for Arterial Cannulation in Adult Patients

Local Warming Technique for Arterial Cannulation in Adult Patients Under Heart Surgery-A Randomized Controlled Trial

Based on the fact that arterial vasodilation can be advantageous for endovascular catheterization and that an increase in body temperature can cause vasodilation by activating the cholinergic active vasodilator system, this study was planned to observe whether there was a significant change in the diameter of artery through ultrasound and to confirm the effectiveness of heating in the traditional palpation technique and the US-guided technique after local warming of the insertion site of arterial catheter in adult patients undergoing cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Cardiac Disease Which Should be Treated by Surgery
• Intervention / Treatment: Procedure: warming to increase local skin (puncture site) temperature

Detailed Description

Arterial cannulation is one of the important clinical techniques commonly used for real-time monitoring of blood pressure changes or when repeated blood tests are required. However, complications such as bleeding, hematoma, and vascular occlusion may occur if the operator has little or no experience in the procedure, or if arterial cannulation is not easy due to the patient's underlying disease and systemic factors. This situation prolongs the anesthesia induction time and may cause great harm to the patient in cases with a high bleeding tendency, such as in cardiac surgery. Various studies have reported various arterial cannulation techniques so far, and there have been many advances in arterial cannulation techniques due to the general use of ultrasound (hereafter US). However, there is still a risk of complications due to inexperience in the use of US or poor vascular status of the patient.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan, Korea, Republic of
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients over 18 years of age undergoing cardiac surgery under general anesthesia

Exclusion Criteria:

• If the patient already has an arterial catheter and does not need additional arterial cannulation.
• When arterial cannulation is performed on an artery other than the radial artery due to the surgical technique or the patient's condition.
• When the patient's condition is urgent, such as emergency surgery, and there is no time to proceed with the research.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: non-warming group; non-warming of local skin (puncture site)
Active Comparator: warming group; warming to increase local skin (puncture site) temperature	Procedure: warming to increase local skin (puncture site) temperature; According to the group of participants, investigator applies the warmer to the hands and wrists of the participants, makes a local temperature of 40℃ gradually, and maintains it for about 10 minutes in warming group (which is divided in to warming-palpation (WP) and warming-US (WU) group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of the diameter of the artery	Investigator measures where there is a significant increase in the diameter of the artery due to warming using US.	from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)
changes of the cross-sectional area of the artery	Investigator measures where there is a significant increase in the cross-sectional area of the artery due to warming using US.	from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)
Success rate of first trial for arterial cannulation	Investigator measures success rate of first trial for arterial cannulation.	from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications related with arterial cannulation	Investigator measures where there are complications such as hematoma, vasopasm, and ischemia.	from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Hee Young Kim, MD, PhD, Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): March 29, 2022
• Study Completion (Actual): March 29, 2022

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 05-2021-117

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