Cardiac Disease Which Should be Treated by SurgeryNCT04969692
Local Warming Technique for Arterial Cannulation in Adult Patients
A study testing warming to increase local skin (puncture site) temperature in people with Cardiac Disease Which Should be Treated by Surgery, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease Which Should be Treated by Surgery
- What is being tested?
- warming to increase local skin (puncture site) temperature
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2021to 29 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 18 years of age undergoing cardiac surgery under general anesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- warming to increase local skin (puncture site) temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warming to increase local skin (puncture site) temperatureProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| non-warming group | No intervention | non-warming of local skin (puncture site) |
| warming group | Active comparator | warming to increase local skin (puncture site) temperature Receives: Procedure: warming to increase local skin (puncture site) temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)
Secondary outcomes (1)
Complications related with arterial cannulation
Investigator measures where there are complications such as hematoma, vasopasm, and ischemia.
Measured: from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start5 Jul 2021
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Disease Which Should be Treated by SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, MD, PhD, Principal investigator, Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969692
- Sponsor's protocol ID
- 05-2021-117
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37969298
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Warming Technique for Arterial Cannulation in Adult Patients Under Heart Surgery-A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04969692
- Acronym / sponsor ID
- 05-2021-117
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-warming group | No intervention | –non-warming of local skin (puncture site) |
| warming group | Active comparator | Procedure: warming to increase local skin (puncture site) temperaturewarming to increase local skin (puncture site) temperature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients over 18 years of age undergoing cardiac surgery under general anesthesia
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| warming to increase local skin (puncture site) temperatureAccording 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). | Procedure or surgery | warming group |
Primary outcome
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.
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.
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.
1 secondary outcome
Complications related with arterial cannulation
Time frame: from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 37969298Park 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Young Kim, MD, PhD principal investigator
Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warming to increase local skin (puncture site) temperature in people with Cardiac Disease Which Should be Treated by Surgery, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04969692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.