## Protocol Section
### Identification Module
**NCT ID:** NCT06417021

**Brief Title:** Ergonomics in Ultrasound Procedures

**Official Title:** The Position of the Ultrasound Machine in the Placement of the Central Venous Catheter: a Randomized Controlled Study

#### Organization Study ID Info
**ID:** 25148/2024
#### Organization
**Class:** OTHER
**Full Name:** University of Padova
### Status Module
#### Completion Date
**Date:** 2025-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-25

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-09
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Padova

#### Responsible Party

**Investigator Affiliation:** University of Padova

**Investigator Full Name:** Alessandro De Cassai

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study will compare two different positions of the ultrasound machine during simulated CVC positioning.

The position of the ultrasound machine will be randomized. Group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.

**Detailed Description:** We will recruit medical trainees affiliated with the 'Anesthesia and Intensive Care' and 'Emergency Medicine' schools. Data collected for each participant will include: age, gender, specialty school, year of specialization training, expertise in using ultrasound for ultrasound-guided procedures. Once informed consent is obtained, subjects will be divided through simple randomization (a list generated in advance with Excel and subjected to the opaque envelope method) into two groups: A and B. All subjects will be asked to perform CVC placement using the simulator through an 'oblique in-plane' approach. Subjects randomized to group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.

### Conditions Module

**Conditions:**

- Procedural Complication

- Competence

**Keywords:**

- Central Venous Access

- Ultrasound

- Ergonomics

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** A clip of the ultrasound procedure will be saved and reviewed by a blind assessor that will value the quality of the procedure

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 254

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will simulate a CVC positioning keeping the ultrasound machine facing them

**Intervention Names:**

- Other: Frontal Ultrasound Machine

**Label:** Frontal position of Ultrasound machine (Ergonomic group)

**Type:** OTHER

#### Arm Group 2

**Description:** Participants will simulate a CVC positioning keeping the ultrasound machine in a lateral position on the same side of the needle.

**Intervention Names:**

- Other: Lateral Ultrasound Machine

**Label:** Lateral position (90°) of Ultrasound machine (No Ergonomic group)

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Frontal position of Ultrasound machine (Ergonomic group)

**Description:** Ultrasound machine will be placed in a frontal position

**Name:** Frontal Ultrasound Machine

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Lateral position (90°) of Ultrasound machine (No Ergonomic group)

**Description:** Ultrasound machine will be placed in a lateral position

**Name:** Lateral Ultrasound Machine

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Investigators will measure time needed to correctly perform the procedure in seconds. The chronometer will be started when the participant takes the ultrasound probe and will be stopped when the guidewire will be correctly placed

**Measure:** Time to correct CVC position

**Time Frame:** baseline

#### Secondary Outcomes

**Description:** Procedure will be recorded as a clip in ultrasound machine. A blind assessor will evaluate the clip using the following scale (1-During the advancement of the needles, only the distortion of the tissue could be observed.

2-Only the tip of the needle was visible. 3-The tip of the needle was visible throughout the advancement, but the body of the needle was only partially visible.

4-The needle was completely visible during its advancement.)

**Measure:** Needle tip visualization

**Time Frame:** baseline

**Description:** A complication is defined as participants puncturing the arterial vessel of the simulator

**Measure:** Complications

**Time Frame:** baseline

**Description:** Procedure will be considered successful if participants will be able to insert the guidewire in a 10 minutes timeframe

**Measure:** Success of the procedure

**Time Frame:** 10 minutes from the baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 'Anesthesia and Intensive Care' and 'Emergency Medicine' residents
* Informed consent

Exclusion Criteria:

* None

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** alessandro.decassai@aopd.veneto.it

**Name:** Alessandro De Cassai, MD

**Phone:** 0498216739

**Phone Ext:** 0039

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Padova

**Country:** Italy

**Facility:** University Hospital of Padova

**State:** Veneto

**Zip:** 35127

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
