Cardiac Surgery in Adult PatientNCT07400627
Direct vs. Seldinger Technique for Ultrasound-Guided Difficult Radial Access in Cardiac Surgery
A study testing Ultrasound-Guided Direct Cannulation Technique and Ultrasound-Guided Seldinger Cannulation Technique in people with Cardiac Surgery in Adult Patient and Cardiac Surgery, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Radial artery cannulation is a routine procedure for invasive hemodynamic monitoring for patients undergoing cardiovascular surgery patients. Although ultrasound (USG) guidance is known to improve success rates, there is limited data comparing the efficacy of the 'Direct' versus 'Seldinger' techniques specifically in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery in Adult Patient, Cardiac Surgery, Radial Artery Cannulation
- What is being tested?
- Ultrasound-Guided Direct Cannulation Technique and Ultrasound-Guided Seldinger Cannulation Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients aged 18 years or older
- American Society of Anesthesiologists (ASA) physical status I-IV
- Patients scheduled for cardiovascular surgery requiring invasive arterial monitoring
Who cannot join
- Patients undergoing emergency surgery
- Coagulation disorders or known coagulopathy
- Presence of an arteriovenous fistula
- Patients in shock or hemodynamically instable
- Patients requiring mechanical circulatory support
- History of Raynaud's phenomenon
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, 06170
Dilek ÜNAL, Professor, +905336957855, dilekunalmd@gmail.com
Dilek ÜNAL, Professor
About this study
Official title: Comparison of the Effectiveness of Ultrasound-Guided Direct and Seldinger Cannulation Techniques in Patients With Anticipated Difficult Radial Artery Cannulation Undergoing Cardiac Surgery
Radial artery cannulation is a routine procedure for invasive hemodynamic monitoring for patients undergoing cardiovascular surgery patients.
Although ultrasound (USG) guidance is known to improve success rates, there is limited data comparing the efficacy of the 'Direct' versus 'Seldinger' techniques specifically in patients with anticipated difficult radial access.
This study aims to compare the effectiveness of USG-guided Direct cannulation and USG-guided Seldinger techniques in adult patients with anticipated difficult radial arterial cannulation.
Read the detailed description
Study Protocol and Patient Assessment: Data collection and the procedural intervention will be performed in the preoperative period, prior to the induction of anesthesia. All patients will undergo a modified Allen test. The radial artery site will be selected based on the following hierarchy: preferably the non-dominant hand (unless surgical plan dictates otherwise), an arm with no history of coronary angiography, and the side determined to be easiest for cannulation via ultrasound (USG) assessment.
Ultrasound Assessment and Exclusion: A 12 MHz linear ultrasound probe will be used for all assessments and procedures. Before the intervention, a detailed sonographic evaluation of the radial artery will be recorded, including:
- Artery diameter and wall thickness
- Lumen continuity and flow velocity
- Presence of calcification, vessel irregularity, or tortuosity
- Stenosis (percentage) and plaque characterization (stable/unstable; fibrous/fatty)
- Presence of hematoma, posterior wall injury, or dissection
- Skin- mid radial artery distance Patients with significant stenosis where an appropriate arterial segment matching the cannula diameter and length cannot be identified will be excluded from the study, and cannulation will be performed at an alternative site.
Randomization and Positioning: Patients will be randomized into two groups using a computer-generated random number table:
- Group D (Direct): Cannulation performed using the catheter-over-needle technique.
- Group S (Seldinger): Cannulation performed using the catheter-over-guide-wire technique.
The patient's arm will be abducted, and the wrist will be extended and fixed over a small support. Standard aseptic preparation and draping will be performed.
Procedural Definitions and Outcome Measures: The procedure will be performed under real-time ultrasound guidance. The following time intervals and metrics will be recorded:
- Radial artery cannulation time: Defined as the time elapsed from the initial skin contact of the needle/cannula to the appearance of the radial artery pressure waveform
- Radial artery puncture time: Defined as the time elapsed from the initial skin contact of the needle/cannula to the appearance of blood in the hub Number of puncture: The total number of skin punctures required to achieve successful cannulation.
Number of needle maneuvers: The total number of needle advancements towards the artery
Safety and Follow-up: If arterial cannulation fails, manual compression will be applied to the artery for 5 minutes to prevent hematoma formation. All patients will be monitored for complications (such as hematoma, ischemia, or nerve injury) for 24 hours post-procedure.
- Conditions
- Cardiac Surgery in Adult Patient, Cardiac Surgery, Radial Artery Cannulation, Arterial Cannulation, Radial Artery Catheterization
- Being tested
- Ultrasound-Guided Direct Cannulation Technique, Ultrasound-Guided Seldinger Cannulation Technique
- Keywords
- difficult radial artery cannulation, direct technique for radial artery cannulation, Seldinger technique for radial artery cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Direct Cannulation TechniqueProcedure or surgery
Radial artery cannulation performed using the direct puncture technique (catheter-over-needle) under real-time ultrasound guidance.
Ultrasound-Guided Seldinger Cannulation TechniqueProcedure or surgery
Radial artery cannulation performed using the Seldinger technique (catheter-over-guide-wire) under real-time ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Direct Cannulation Technique | Experimental | Patients in this group will undergo radial artery cannulation using the ultrasound-guided direct technique. Receives: Procedure: Ultrasound-Guided Direct Cannulation Technique |
| Ultrasound-Guided Seldinger Cannulation Technique | Active comparator | Patients in this group will undergo radial artery cannulation using the ultrasound-guided Seldinger technique. Receives: Procedure: Ultrasound-Guided Seldinger Cannulation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-Attempt Cannulation Success Rate
The proportion of patients in whom radial artery cannulation is successfully performed (verified by the appearance of the arterial pressure waveform on the monitor) with a single skin puncture
Measured: 10 min before anesthesia induction
Secondary outcomes (3)
Number of Cannulation Attempts
The total number of skin punctures required to achieve successful radial artery cannulation
Measured: 10 min before anesthesia induction
Radial artery cannulation time
Total time elapsed from the initial skin contact with the arterial cannula to the visualization of the arterial waveform on the monitor.
Measured: 10 min before anesthesia induction
Incidence of Procedure-Related Complications
Evaluation of adverse events associated with the cannulation procedure, including hematoma, arterial dissection, posterior wall injury, nerve injury, or infection
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgery in Adult PatientStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Dilek ÜNAL, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400627
- Sponsor's protocol ID
- AEŞH-EK-2025-221
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdel-Kader, A. , Kaushal, N. , Shah, R. , Gomulka, M. , Wang, T. and Shulman, S. (2016) A Novel Technique to Maintain Radial Arterial Catheter Position: The Arterial Catheter Stabilizer. Open Journal of Anesthesiology, 6, 193-197. doi: 10.4236/ojanes.2016.612029.
Sung JM, Jun YE, Jung YD, Kim KN. Comparison of an Ultrasound-Guided Dynamic Needle Tip Positioning Technique and a Long-Axis In-Plane Technique for Radial Artery Cannulation in Older Patients: A Prospective, Randomized, Controlled Study. J Cardiothorac Vasc Anesth. 2023 Dec;37(12):2475-2481. doi: 10.1053/j.jvca.2023.08.138. Epub 2023 Aug 25.
PubMed 37741770Mesa BK, Sinha M, Kumar M, Ramchandani S, Dey C, Agrawal N, Khetarpal M. Radial Arterial Cannulation by Ultrasound-Guided Dynamic Needle-Tip Positioning Using the Short-Axis Out-of-Plane Approach Versus the Long-Axis In-Plane Approach: A Randomized Controlled Study. Cureus. 2024 Feb 14;16(2):e54183. doi: 10.7759/cureus.54183. eCollection 2024 Feb.
PubMed 38496072Nam K, Jeon Y, Yoon S, Kwon SM, Kang P, Cho YJ, Kim TK. Ultrasound-guided radial artery cannulation using dynamic needle tip positioning versus conventional long-axis in-plane techniques in cardiac surgery patients: a randomized, controlled trial. Minerva Anestesiol. 2020 Jan;86(1):30-37. doi: 10.23736/S0375-9393.19.13646-2. Epub 2019 Jun 17.
PubMed 31213045
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound-Guided Direct and Seldinger Cannulation Techniques in Patients With Anticipated Difficult Radial Artery Cannulation Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07400627
- Acronym / sponsor ID
- AEŞH-EK-2025-221
- Conditions
- Cardiac Surgery in Adult Patient, Cardiac Surgery, Radial Artery Cannulation, Arterial Cannulation, Radial Artery Catheterization
- Keywords
- difficult radial artery cannulation, direct technique for radial artery cannulation, Seldinger technique for radial artery cannulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Feb 2026 (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.
Radial artery cannulation is a routine procedure for invasive hemodynamic monitoring for patients undergoing cardiovascular surgery patients.
Although ultrasound (USG) guidance is known to improve success rates, there is limited data comparing the efficacy of the 'Direct' versus 'Seldinger' techniques specifically in patients with anticipated difficult radial access.
This study aims to compare the effectiveness of USG-guided Direct cannulation and USG-guided Seldinger techniques in adult patients with anticipated difficult radial arterial cannulation.
Detailed description
Study Protocol and Patient Assessment: Data collection and the procedural intervention will be performed in the preoperative period, prior to the induction of anesthesia. All patients will undergo a modified Allen test. The radial artery site will be selected based on the following hierarchy: preferably the non-dominant hand (unless surgical plan dictates otherwise), an arm with no history of coronary angiography, and the side determined to be easiest for cannulation via ultrasound (USG) assessment.
Ultrasound Assessment and Exclusion: A 12 MHz linear ultrasound probe will be used for all assessments and procedures. Before the intervention, a detailed sonographic evaluation of the radial artery will be recorded, including:
- Artery diameter and wall thickness
- Lumen continuity and flow velocity
- Presence of calcification, vessel irregularity, or tortuosity
- Stenosis (percentage) and plaque characterization (stable/unstable; fibrous/fatty)
- Presence of hematoma, posterior wall injury, or dissection
- Skin- mid radial artery distance Patients with significant stenosis where an appropriate arterial segment matching the cannula diameter and length cannot be identified will be excluded from the study, and cannulation will be performed at an alternative site.
Randomization and Positioning: Patients will be randomized into two groups using a computer-generated random number table:
- Group D (Direct): Cannulation performed using the catheter-over-needle technique.
- Group S (Seldinger): Cannulation performed using the catheter-over-guide-wire technique.
The patient's arm will be abducted, and the wrist will be extended and fixed over a small support. Standard aseptic preparation and draping will be performed.
Procedural Definitions and Outcome Measures: The procedure will be performed under real-time ultrasound guidance. The following time intervals and metrics will be recorded:
- Radial artery cannulation time: Defined as the time elapsed from the initial skin contact of the needle/cannula to the appearance of the radial artery pressure waveform
- Radial artery puncture time: Defined as the time elapsed from the initial skin contact of the needle/cannula to the appearance of blood in the hub Number of puncture: The total number of skin punctures required to achieve successful cannulation.
Number of needle maneuvers: The total number of needle advancements towards the artery
Safety and Follow-up: If arterial cannulation fails, manual compression will be applied to the artery for 5 minutes to prevent hematoma formation. All patients will be monitored for complications (such as hematoma, ischemia, or nerve injury) for 24 hours post-procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomised
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Direct Cannulation Technique | Experimental | Procedure: Ultrasound-Guided Direct Cannulation TechniquePatients in this group will undergo radial artery cannulation using the ultrasound-guided direct technique. |
| Ultrasound-Guided Seldinger Cannulation Technique | Active comparator | Procedure: Ultrasound-Guided Seldinger Cannulation TechniquePatients in this group will undergo radial artery cannulation using the ultrasound-guided Seldinger technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older
- American Society of Anesthesiologists (ASA) physical status I-IV
- Patients scheduled for cardiovascular surgery requiring invasive arterial monitoring
Key exclusion criteria (7 listed)
- Patients undergoing emergency surgery
- Coagulation disorders or known coagulopathy
- Presence of an arteriovenous fistula
- Patients in shock or hemodynamically instable
- Patients requiring mechanical circulatory support
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 |
|---|---|---|
| Ultrasound-Guided Direct Cannulation TechniqueRadial artery cannulation performed using the direct puncture technique (catheter-over-needle) under real-time ultrasound guidance. | Procedure or surgery | Ultrasound-Guided Direct Cannulation Technique |
| Ultrasound-Guided Seldinger Cannulation TechniqueRadial artery cannulation performed using the Seldinger technique (catheter-over-guide-wire) under real-time ultrasound guidance. | Procedure or surgery | Ultrasound-Guided Seldinger Cannulation Technique |
Primary outcome
First-Attempt Cannulation Success Rate
Time frame: 10 min before anesthesia induction
The proportion of patients in whom radial artery cannulation is successfully performed (verified by the appearance of the arterial pressure waveform on the monitor) with a single skin puncture
3 secondary outcomes
Number of Cannulation Attempts
Time frame: 10 min before anesthesia induction
Radial artery cannulation time
Time frame: 10 min before anesthesia induction
Incidence of Procedure-Related Complications
Time frame: Postoperative 24th hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- BackgroundAbdel-Kader, A. , Kaushal, N. , Shah, R. , Gomulka, M. , Wang, T. and Shulman, S. (2016) A Novel Technique to Maintain Radial Arterial Catheter Position: The Arterial Catheter Stabilizer. Open Journal of Anesthesiology, 6, 193-197. doi: 10.4236/ojanes.2016.612029.
- Background: PubMed 37741770Sung JM, Jun YE, Jung YD, Kim KN. Comparison of an Ultrasound-Guided Dynamic Needle Tip Positioning Technique and a Long-Axis In-Plane Technique for Radial Artery Cannulation in Older Patients: A Prospective, Randomized, Controlled Study. J Cardiothorac Vasc Anesth. 2023 Dec;37(12):2475-2481. doi: 10.1053/j.jvca.2023.08.138. Epub 2023 Aug 25.
- Background: PubMed 38496072Mesa BK, Sinha M, Kumar M, Ramchandani S, Dey C, Agrawal N, Khetarpal M. Radial Arterial Cannulation by Ultrasound-Guided Dynamic Needle-Tip Positioning Using the Short-Axis Out-of-Plane Approach Versus the Long-Axis In-Plane Approach: A Randomized Controlled Study. Cureus. 2024 Feb 14;16(2):e54183. doi: 10.7759/cureus.54183. eCollection 2024 Feb.
- Background: PubMed 31213045Nam K, Jeon Y, Yoon S, Kwon SM, Kang P, Cho YJ, Kim TK. Ultrasound-guided radial artery cannulation using dynamic needle tip positioning versus conventional long-axis in-plane techniques in cardiac surgery patients: a randomized, controlled trial. Minerva Anestesiol. 2020 Jan;86(1):30-37. doi: 10.23736/S0375-9393.19.13646-2. Epub 2019 Jun 17.
- Individual participant dataSharing planned: No
Related trials for Cardiac Surgery in Adult Patient
Not yet recruitingObservational study
Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients
Frailty, Suboptimal Mask Ventilation
Recruiting
Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients
Pain, Acute, Pain, Chronic
RecruitingObservational study
Frailty and Ultrasound-Guided Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients
Frailty, Cardiac Surgery
RecruitingObservational study
PROPOSAL FOR A PREOPERATIVE FUNCTIONAL OPTIMIZATION PATHWAY FOR PATIENTS CANDIDATE FOR MAJOR SURGERY (CARDIAC AND ABDOMINAL ONCOLOGY)
Prehabilitation, Major Abdominal Surgeries
RecruitingObservational study
Heart Rate Variability Changes and Postoperative Delirium After Major Abdominal Surgery
Postoperative Delirium (POD), Heart Rate Variability (HRV)
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.
Dilek ÜNAL principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Direct Cannulation Technique and Ultrasound-Guided Seldinger Cannulation Technique in people with Cardiac Surgery in Adult Patient and Cardiac Surgery, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 10 Feb 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek ÜNAL, Professor (+905336957855, dilekunalmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-Attempt Cannulation Success Rate (time frame: 10 min before anesthesia induction). 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 NCT07400627, which also lists 4 linked publications.
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 10 Feb 2026.