## Protocol Section
### Identification Module
**NCT ID:** NCT06422195

**Brief Title:** Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach

**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

#### Organization Study ID Info
**ID:** 36197/12/22
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-19

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tanta University

#### Responsible Party

**Investigator Affiliation:** Tanta University

**Investigator Full Name:** Maram Ibrahim Elmazny

**Investigator Title:** Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**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

### Conditions Module

**Conditions:**

- Dynamic Needle Tip Positioning

- Short Axis

- Arterial Cannulation

- Long Axis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 164

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

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

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

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Long Axis Approach (LA)

**Label:** Long Axis Approach (LA)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

**Description:** 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.

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

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Long Axis Approach (LA)

**Description:** 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.

**Name:** Long Axis Approach (LA)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Time to achieve successful cannulation will be measured from initial skin puncture until the catheter is placed into the radial artery.

**Measure:** Time to achieve successful cannulation

**Time Frame:** Immediately after catheterization

#### Secondary Outcomes

**Description:** The success rate in the first trial of insertion between the two different approaches will be assessed.

**Measure:** The success rate

**Time Frame:** Immediately after catheterization

**Description:** Number of attempts till successful arterial cannula insertion will be recorded.

**Measure:** Number of attempts till successful arterial cannula insertion

**Time Frame:** Immediately after catheterization

**Description:** Complications including edema, hematoma, vasospasm, ischemia, thrombosis and nerve injury will be recorded.

**Measure:** Incidence of complications

**Time Frame:** 24 hours postoperatively

**Description:** Operators' satisfaction (Level of operators' satisfaction will be assessed with a Scale from 1-5)

**Measure:** Operators' satisfaction

**Time Frame:** Immediately after catheterization

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Maramelmazny705@gmail.com

**Name:** Maram I Elmazny, MD

**Phone:** 00201014137093

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tanta

**Contacts:**

***Contact 1:***

- **Email:** Maramelmazny705@gmail.com

- **Name:** Maram I Elmazny, MD

- **Phone:** 00201014137093

- **Role:** CONTACT

***Contact 2:***

- **Name:** Sarah A Afifi, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Egypt

**Facility:** Tanta University

**State:** El-Gharbia

**Status:** RECRUITING

**Zip:** 31527

### IPD Sharing Statement Module

**Access Criteria:** The data will be available upon a reasonable request from the corresponding author.

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

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** After the end of study for one year.

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
