Dynamic Needle Tip PositioningNCT06422195
Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach
A study testing Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) and Long Axis Approach (LA) in people with Dynamic Needle Tip Positioning and Short Axis, run by Tanta University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dynamic Needle Tip Positioning, Short Axis, Arterial Cannulation
- What is being tested?
- Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) and Long Axis Approach (LA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteEgypt
- Study dates
- 19 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA), Long Axis Approach (LA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Long Axis Approach (LA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after catheterization
Secondary outcomes (4)
The success rate
The success rate in the first trial of insertion between the two different approaches will be assessed.
Measured: Immediately after catheterization
Number of attempts till successful arterial cannula insertion
Number of attempts till successful arterial cannula insertion will be recorded.
Measured: Immediately after catheterization
Incidence of complications
Complications including edema, hematoma, vasospasm, ischemia, thrombosis and nerve injury will be recorded.
Measured: 24 hours postoperatively
Operators' satisfaction
Operators' satisfaction (Level of operators' satisfaction will be assessed with a Scale from 1-5)
Measured: Immediately after catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start19 May 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dynamic Needle Tip PositioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Ibrahim Elmazny, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422195
- Sponsor's protocol ID
- 36197/12/22
- Status last verified
- Apr 2025
- First submitted
- 14 May 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
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.
PubMed 41239242
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06422195
- Acronym / sponsor ID
- 36197/12/22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 19 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) | Experimental | 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) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) |
| 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. | Other | Long Axis Approach (LA) |
Primary outcome
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.
4 secondary outcomes
The success rate
Time frame: Immediately after catheterization
Number of attempts till successful arterial cannula insertion
Time frame: Immediately after catheterization
Incidence of complications
Time frame: 24 hours postoperatively
Operators' satisfaction
Time frame: Immediately after catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 41239242Elmazny 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.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Dynamic Needle Tip Positioning
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) and Long Axis Approach (LA) in people with Dynamic Needle Tip Positioning and Short Axis, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve successful cannulation (time frame: Immediately after catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06422195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.