Local Warming Technique for Arterial Cannulation in Adult Patients

Sponsor

Pusan National University Yangsan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04969692

Collaborator

(none)

160

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease Which Should be Treated by Surgery	Procedure: warming to increase local skin (puncture site) temperature	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 5, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: non-warming group
Active Comparator: warming group	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).

Arm

Intervention/Treatment

No Intervention: non-warming group

Active Comparator: warming group

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).

Outcome Measures

Primary Outcome Measures

changes of the diameter of the artery [from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)]
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 [from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)]
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 [from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)]
Investigator measures success rate of first trial for arterial cannulation.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Yangsan Hospital	Yangsan		Korea, Republic of

Sponsors and Collaborators

Pusan National University Yangsan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kim Hee Young, Clinical associate professor, Pusan National University Yangsan Hospital

ClinicalTrials.gov Identifier:

NCT04969692

Other Study ID Numbers:

05-2021-117

First Posted:

Jul 21, 2021

Last Update Posted:

Jul 21, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Study Results

No Results Posted as of Jul 21, 2021