Local Warming Technique for Arterial Cannulation in Adult Patients

NCT ID: NCT04969692

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-05

Study Completion Date

2022-03-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Disease Which Should be Treated by Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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non-warming group

non-warming of local skin (puncture site)

Group Type NO_INTERVENTION

No interventions assigned to this group

warming group

warming to increase local skin (puncture site) temperature

Group Type ACTIVE_COMPARATOR

warming to increase local skin (puncture site) temperature

Intervention Type PROCEDURE

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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Yangsan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kim Hee Young

Clinical associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee Young Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University

Locations

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Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status

Countries

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South Korea

References

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Park S, Kim HJ, Heo W, Shin SW, Yoon JU, Byeon GJ, Lee J, Jung J, Kim HY. Effect of local warming for arterial catheterization in adult cardiac surgery: a randomized controlled trial. J Thorac Dis. 2023 Oct 31;15(10):5330-5339. doi: 10.21037/jtd-23-820. Epub 2023 Sep 18.

Reference Type DERIVED
PMID: 37969298 (View on PubMed)

Other Identifiers

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05-2021-117

Identifier Type: -

Identifier Source: org_study_id

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