ClinicalTrials.gg
Not yet recruitingNCT07400627Updated Feb 10, 2026

Direct vs. Seldinger Technique for Ultrasound-Guided Difficult Radial Access in Cardiac Surgery

An interventional study of Ultrasound-Guided Direct Cannulation Technique and Ultrasound-Guided Seldinger Cannulation Technique in Cardiac Surgery in Adult Patient, Cardiac Surgery and Radial Artery Cannulation, sponsored by Diskapi Teaching and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by Diskapi Teaching and Research Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Diskapi Teaching and Research Hospital is the lead sponsor of 106 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 years or older
  • (ASA) physical status I-IV
  • Patients scheduled for cardiovascular surgery requiring invasive arterial monitoring

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
242 participants (estimated)

Study arms

  • Experimental
    Ultrasound-Guided Direct Cannulation Technique

    Patients in this group will undergo radial artery cannulation using the ultrasound-guided direct technique.

    Procedure: Ultrasound-Guided Direct Cannulation Technique

  • Active comparator
    Ultrasound-Guided Seldinger Cannulation Technique

    Patients in this group will undergo radial artery cannulation using the ultrasound-guided Seldinger technique.

    Procedure: Ultrasound-Guided Seldinger Cannulation Technique

Interventions

  • ProcedureUltrasound-Guided Direct Cannulation Technique

    Radial artery cannulation performed using the direct puncture technique (catheter-over-needle) under real-time ultrasound guidance.

  • ProcedureUltrasound-Guided Seldinger Cannulation Technique

    Radial artery cannulation performed using the Seldinger technique (catheter-over-guide-wire) under real-time ultrasound guidance.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 min before anesthesia induction

Secondary outcomes

  1. Number of Cannulation Attempts

    The total number of skin punctures required to achieve successful radial artery cannulation

    Time frame: 10 min before anesthesia induction

  2. 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.

    Time frame: 10 min before anesthesia induction

  3. 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

    Time frame: Postoperative 24th hour

07

Study locations

1 site
08

References and documents

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 37741770 ↗
  • Mesa 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 38496072 ↗
  • Nam 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2026; primary completion for Sep 2026, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 3, 2026
First posted
Feb 10, 2026
StartEst.
Mar 1, 2026
Primary completionEst.
Sep 1, 2026
CompletionEst.
Sep 30, 2026
Last update
Feb 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07400627
Responsible party
DILEK YAZICIOGLU (Professor of Anesthesiology, Diskapi Teaching and Research Hospital) — Principal investigator
First posted
Feb 10, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Feb 10, 2026

Study contacts

Dilek ÜNAL, Professor
Contact
dilekunalmd@gmail.com
+905336957855
Dilek ÜNAL
principal investigator · Saglik Bilimleri Universitesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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