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NCT Number: NCT07400627

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Location contact

Dilek ÜNAL, Professor

CONTACT

[email protected]

+905336957855

Dilek ÜNAL, Professor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

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

Treatment and study plan

Ultrasound-Guided Direct Cannulation Technique

Procedure

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

Ultrasound-Guided Seldinger Cannulation Technique

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Cannulation Attempts

    Time frame: 10 min before anesthesia induction

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

  2. Radial artery cannulation time

    Time frame: 10 min before anesthesia induction

    Total time elapsed from the initial skin contact with the arterial cannula to the visualization of the arterial waveform on the monitor.

  3. Incidence of Procedure-Related Complications

    Time frame: Postoperative 24th hour

    Evaluation of adverse events associated with the cannulation procedure, including hematoma, arterial dissection, posterior wall injury, nerve injury, or infection

Study contacts

Contact information is provided by the study sponsor or research team.

Dilek ÜNAL, Professor

CONTACT

[email protected]

+905336957855

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

Comparison of the Effectiveness of Ultrasound-Guided Direct and Seldinger Cannulation Techniques in Patients With Anticipated Difficult Radial Artery Cannulation Undergoing Cardiac Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

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.

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