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Completed

NCT Number: NCT04969692

Local Warming Technique for Arterial Cannulation in Adult Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

warming to increase local skin (puncture site) temperature

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).

Primary outcomes

  1. changes of the diameter of the artery

    Time frame: 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.

  2. changes of the cross-sectional area of the artery

    Time frame: 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.

  3. 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)

    Investigator measures success rate of first trial for arterial cannulation.

Secondary outcomes

  1. Complications related with arterial cannulation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2021
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.