]>
IRCT20161127031131N4 IRCT 2022-05-10 Iran University of Medical Sciences Guided radial artery cannulation in patient undergoing cardiac Comparison of ultrasound-guided radial artery cannulation with Doppler guidance technique and palpation technique in patient undergoing cardiac surgery referred to Shahid Rajaei Heart Center in Tehran: A clinical trial 2022-05-22 anticipated 300 Complete https://irct.ir/trial/63132 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are randomly assigned to three equal groups and for random allocation, permuted block randomization with hexagonal blocks is used, Blinding description: In this study, the patient is unaware of which group he is in, but the patient's caregivers (physician and nurse) and statistical analyst are aware. In this study, after obtaining the patient's consent, it is explained that he is in one of the three groups of touch, Doppler or ultrasound. N/A Radial artery cannulation. Intervention 1: Control group: For cannulation with palpation technique , the anesthesiologist touches the pulse of the radial artery with a non-dominant hand. The catheter will be advanced towards the radial artery, at 15–30 degrees to the skin, until blood observes in the catheter hub, Guidewire is then inserted through the needle. The leader catheter is then connected to the transducer so that arterial waves appear on the monitoring screen. Intervention 2: Intervention group: Doppler group: In the Doppler-guided radial artery cannulation method, the Doppler probe is placed in the non-dominant hand of the anesthesiologist to determine the location of the highest pulsating signal. The needle is inserted through the anesthetized skin. An increase or decrease in Doppler tone is a sign that the needle is being pressed against the artery. The needle is then pushed forward until the Doppler tone returns to baseline (indicating reopening of the artery) or pulsating blood appears at the end of the needle. Guidewire is then inserted through the needle and after removing the needle, the leader catheter is placed in place. The leader catheter is then connected to the transducer so that arterial waves appear on the monitoring screen. Intervention 3: Intervention group: Ultrasound group: For ultrasound-guided arterial cannulation, the ultrasound probe detects the radial artery perpendicular to its longitudinal axis approximately 5 mm proximal to the skin puncture site. The needle is pushed at an angle of 15-30 degrees to the skin until the catheter tip is visible on the screen. The position of the catheter is adjusted until the tip of the catheter comes in contact with the artery. Guidewire is then inserted through the needle and after removing the needle, the leader catheter is placed in place. The leader catheter is then connected to the transducer so that arterial waves appear on the monitoring screen. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Data will be available after the article is published To whom: Information will be available to academic researchers Conditions: Use of information is permitted provided the source is acknowledge Where to obtain: Applicants can request the required information by sending an email to yasmin.chaibakhsh@gmail.com How to obtain: Information will be sent to them within one week of sending the email Comments:
public Yasmin Chaibakhsh Langroudi
Shaheed Rajaie Cardiovascular, Medical & Research Center
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 yasmin.chaibakhsh@gmail.com Iran University of Medical Sciences scientific Rasoul Azarfarin
Shaheed Rajaie Cardiovascular, Medical & Research Center
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 azarfarinr@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years of age undergoing cardiac surgery 18 years no limit Both Patients under 18 years Patients with peripheral vascular disease Patients with vascular collagen diseases Patients with inflamed skin near the puncture site Patients with cold and mottled skin and weak capillary refill Patients who have undergone radial artery cannulation for the past 30 days Treatment - Devices Treatment - Devices Treatment - Devices Control group: For cannulation with palpation technique , the anesthesiologist touches the pulse of the radial artery with a non-dominant hand. The catheter will be advanced towards the radial artery, at 15–30 degrees to the skin, until blood observes in the catheter hub, Guidewire is then inserted through the needle. The leader catheter is then connected to the transducer so that arterial waves appear on the monitoring screen. Intervention group: Doppler group: In the Doppler-guided radial artery cannulation method, the Doppler probe is placed in the non-dominant hand of the anesthesiologist to determine the location of the highest pulsating signal. The needle is inserted through the anesthetized skin. An increase or decrease in Doppler tone is a sign that the needle is being pressed against the artery. The needle is then pushed forward until the Doppler tone returns to baseline (indicating reopening of the artery) or pulsating blood appears at the end of the needle. Guidewire is then inserted through the needle and after removing the needle, the leader catheter is placed in place. The leader catheter is then connected to the transducer so that arterial waves appear on the monitoring screen. Intervention group: Ultrasound group: For ultrasound-guided arterial cannulation, the ultrasound probe detects the radial artery perpendicular to its longitudinal axis approximately 5 mm proximal to the skin puncture site. The needle is pushed at an angle of 15-30 degrees to the skin until the catheter tip is visible on the screen. The position of the catheter is adjusted until the tip of the catheter comes in contact with the artery. Guidewire is then inserted through the needle and after removing the needle, the leader catheter is placed in place. The leader catheter is then connected to the transducer so that arterial waves appear on the monitoring screen. Success in the first attempt at cannulation. Timepoint: The time of the first puncture. Method of measurement: See blood at the end of the leader cath And measure its time. Cannulation time: It is a measured time from skin puncture to successful cannulation, which is described as the observation of blood at the end of the lead. Timepoint: From skin puncture to successful cannulation, which takes less than 5 minutes, is considered a successful procedure. Method of measurement: Successful cannulation in 5 minutes using a stopwatch. Examination of complications such as arterial spasm, hematoma, infection, thrombosis, ischemia, complex pain syndrome, which will be followed up in the intensive care unit up to 72 hours later. Timepoint: The patient's hand in which the radial artery cannulation has been performed will undergo a clinical examination for complications immediately after the procedure (0), 24, 48 and 72 hours after the procedure. Method of measurement: Physical examination. Iran University of Medical Sciences Approved 2021-09-25 کمیته اخلاق دانشگاه علوم پزشکی ایران Shaheed Rajaie Cardiovascular, Medical & Research Center Tehran Tehran Iran (Islamic Republic of)