- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06422195
Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach
Does the Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach (DNTP - SA) Provides a Faster Ultrasound-guided Arterial Cannulation Than Long Axis (LA) Approach: A Prospective Randomized Controlled Study
Study Overview
Status
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to achieve successful cannulation
Time Frame: Immediately after catheterization
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The success rate
Time Frame: Immediately after catheterization
|
The success rate in the first trial of insertion between the two different approaches will be assessed.
|
Immediately after catheterization
|
|
Number of attempts till successful arterial cannula insertion
Time Frame: Immediately after catheterization
|
Number of attempts till successful arterial cannula insertion will be recorded.
|
Immediately after catheterization
|
|
Operators' satisfaction
Time Frame: Immediately after catheterization
|
Operators' satisfaction (Level of operators' satisfaction will be assessed with a Scale from 1-5)
|
Immediately after catheterization
|
|
Incidence of complications
Time Frame: 24 hours postoperatively
|
Complications including edema, hematoma, vasospasm, ischemia, thrombosis and nerve injury will be recorded.
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 36197/12/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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