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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06422195
Other study ID # 36197/12/22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 19, 2024
Est. completion date September 1, 2024

Study information

Verified date May 2024
Source Tanta University
Contact Maram I Elmazny, MD
Phone 00201014137093
Email Maramelmazny705@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the present study is to compare between Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach (DNTP - SA) and Long Axis (LA) Approach for Ultrasound-guided Arterial Cannulation as regard time to successful arterial cannula insertion as well as the success rate in the first trial of insertion, number of attempts till successful arterial line placemen, complications, and operators' satisfaction.


Description:

Intraoperative Arterial cannulation is recently frequently required especially in high-risk patients or patients with expected major fluid shift. The most common site for arterial cannulation is the radial artery because of ease of accessibility, dual blood supply to the hand via the ulnar artery, and a low rate of complications. Complications from arterial cannulation include thrombosis, hematoma formation, edema and vasospasm. Two approaches are basically identified for ultrasound-guided radial artery cannulation, i.e., short-axis out-of-plane (SA-OOP) and long-axis in-plane (LA-IP) techniques. The dynamic needle tip positioning (DNTP) technique uses the short-axis view of the radial artery with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery


Recruitment information / eligibility

Status Recruiting
Enrollment 164
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Age between 18 and 70 years. - Both sexes. - American Society of Anesthesiologists physical status II-IV. - Patients scheduled for elective surgery procedure that requires the use of invasive arterial pressure monitoring, as determined by the attending anesthesiologist. Exclusion Criteria: - Emergency patients or with Hemodynamic instability. - Patients who have cellulitis or infection at the site of insertion. - Patients with a positive modified Allen test. - Raynaud disease or any Peripheral vascular disease. - Patients with Multiple previous radial artery interventional therapies in the previous 30 days. - Patients scheduled for Surgery at site of insertion like forearm flap. - Refusal to participate by the patient.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)
Ultrasound guided radial artery cannulation by Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. The ultrasound transducer is oriented transversely to the radial artery at the wrist, and the vessel appears as a circular anechoic structure in the ultrasound screen with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery.
Long Axis Approach (LA)
Ultrasound guided radial artery cannulation in Long Axis Approach (LA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. In the LA-IP approach, an ultrasound probe is placed parallel to the radial artery and the artery appears as a tubular anechoic structure in ultrasound.

Locations

Country Name City State
Egypt Tanta University Tanta El-Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to achieve successful cannulation Time to achieve successful cannulation will be measured from initial skin puncture until the catheter is placed into the radial artery. Immediately after catheterization
Secondary The success rate The success rate in the first trial of insertion between the two different approaches will be assessed. Immediately after catheterization
Secondary Number of attempts till successful arterial cannula insertion Number of attempts till successful arterial cannula insertion will be recorded. Immediately after catheterization
Secondary Incidence of complications Complications including edema, hematoma, vasospasm, ischemia, thrombosis and nerve injury will be recorded. 24 hours postoperatively
Secondary Operators' satisfaction Operators' satisfaction (Level of operators' satisfaction will be assessed with a Scale from 1-5) Immediately after catheterization
See also
  Status Clinical Trial Phase
Completed NCT01742416 - Ultrasound Assisted Arterial Cannulation in Small Children N/A