Ankara Etlik City Hospital
Ankara, 06170, Turkey (Türkiye)
Location contact
Dilek ÜNAL, Professor
CONTACT
Dilek ÜNAL, Professor
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07400627
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Ankara, 06170, Turkey (Türkiye)
Dilek ÜNAL, Professor
CONTACT
Dilek ÜNAL, Professor
PRINCIPAL_INVESTIGATOR
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:
Randomization and Positioning: Patients will be randomized into two groups using a computer-generated random number table:
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radial artery cannulation performed using the direct puncture technique (catheter-over-needle) under real-time ultrasound guidance.
Radial artery cannulation performed using the Seldinger technique (catheter-over-guide-wire) under real-time ultrasound guidance.
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
Time frame: 10 min before anesthesia induction
The total number of skin punctures required to achieve successful radial artery cannulation
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.
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
Contact information is provided by the study sponsor or research team.
Diskapi Teaching and Research Hospital
Other
Comparison of the Effectiveness of Ultrasound-Guided Direct and Seldinger Cannulation Techniques in Patients With Anticipated Difficult Radial Artery Cannulation Undergoing Cardiac Surgery
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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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