NCT06422195

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 19, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

May 14, 2024

Last Update Submit

April 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The success rate

    Immediately after catheterization

  • Number of attempts till successful arterial cannula insertion

    Immediately after catheterization

  • Incidence of complications

    24 hours postoperatively

  • Operators' satisfaction

    Immediately after catheterization

Study Arms (2)

Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)

EXPERIMENTAL

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.

Other: Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)

Long Axis Approach (LA)

ACTIVE COMPARATOR

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.

Other: Long Axis Approach (LA)

Interventions

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.

Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)

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.

Long Axis Approach (LA)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (1)

  • Elmazny MI, Ahmed S, Afifi S. Dynamic needle tip positioning in short-axis versus long-axis ultrasound-guided arterial cannulation: a randomised controlled trial. BMC Anesthesiol. 2025 Nov 14;25(1):561. doi: 10.1186/s12871-025-03413-3.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 20, 2024

Study Start

May 19, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations