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Local Warming Technique for Arterial Cannulation in Adult Patients

Primary Purpose

Cardiac Disease Which Should be Treated by Surgery

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
warming to increase local skin (puncture site) temperature
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Disease Which Should be Treated by Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

non-warming group

warming group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
Success rate of first trial for arterial cannulation
Investigator measures success rate of first trial for arterial cannulation.

Secondary Outcome Measures

Complications related with arterial cannulation
Investigator measures where there are complications such as hematoma, vasopasm, and ischemia.

Full Information

First Posted
July 8, 2021
Last Updated
September 26, 2022
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04969692
Brief Title
Local Warming Technique for Arterial Cannulation in Adult Patients
Official Title
Local Warming Technique for Arterial Cannulation in Adult Patients Under Heart Surgery-A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease Which Should be Treated by Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-warming group
Arm Type
No Intervention
Arm Title
warming group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
warming to increase local skin (puncture site) temperature
Intervention Description
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).
Primary Outcome Measure Information:
Title
changes of the diameter of the artery
Description
Investigator measures where there is a significant increase in the diameter of the artery due to warming using US.
Time Frame
from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)
Title
changes of the cross-sectional area of the artery
Description
Investigator measures where there is a significant increase in the cross-sectional area of the artery due to warming using US.
Time Frame
from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)
Title
Success rate of first trial for arterial cannulation
Description
Investigator measures success rate of first trial for arterial cannulation.
Time Frame
from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)
Secondary Outcome Measure Information:
Title
Complications related with arterial cannulation
Description
Investigator measures where there are complications such as hematoma, vasopasm, and ischemia.
Time Frame
from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Local Warming Technique for Arterial Cannulation in Adult Patients

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