## Protocol Section
### Identification Module
**NCT ID:** NCT06433739

**Acronym:** EACEC

**Brief Title:** Efficacy of a Clinical Algorithm for the Selection of Peripheral Venous Catheters

**Official Title:** Efficacy of a Clinical Algorithm for the Selection of Peripheral Venous Catheters to Reduce the Number of Catheter-Associated Complications in Hospitalized Patients: A Retrospective Cohort Study

#### Organization Study ID Info
**ID:** CSAPG-47
#### Organization
**Class:** OTHER
**Full Name:** Consorci Sanitari de l'Alt Penedès i Garraf
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Consorci Sanitari de l'Alt Penedès i Garraf

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this observational study is to investigate the complications associated with peripheral venous catheterization based on whether a correct or incorrect catheter was used according to a clinical algorithm in patients admitted to an acute care unit. The main question it seeks to answer is:

• Are there fewer complications associated with catheterization when a correct catheter choice is made? Data from patients admitted to the acute care units of the sponsoring study center will be reviewed.

### Conditions Module

**Conditions:**

- Catheter Related Complication

**Keywords:**

- Catheterization, Peripheral

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 3314

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This group will include all peripheral venous catheterizations for which the appropriate catheter type selection according to the standardized algorithm has been performed

**Intervention Names:**

- Other: standardized algorithm

**Label:** appropriate catheter type selection

#### Arm Group 2

**Description:** This group will include all peripheral venous catheterizations for which an inappropriate catheter type selection according to the standardized algorithm has been performed

**Intervention Names:**

- Other: standardized algorithm

**Label:** inappropriate catheter type selection

### Interventions

#### Intervention 1

**Arm Group Labels:**

- appropriate catheter type selection

- inappropriate catheter type selection

**Description:** standardized algorithm for the correct selection of peripheral venous catheters

**Name:** standardized algorithm

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of catheters removed due to complications associated with the use of a peripheral venous catheter

**Measure:** Catheters removed due to complications associated with the use of a peripheral venous catheter

**Time Frame:** Through study completion, an average of 1 year

#### Secondary Outcomes

**Description:** Correct or incorrect selection of the catheter according to the clinical algorithm. The proportion of correctly selected catheters in relation to the total number of catheters will be calculated.

**Measure:** Selection of the peripheral venous catheter

**Time Frame:** Through study completion, an average of 1 year

**Description:** Number of complications associated with the use of a peripheral venous catheter depending on whether a correct or incorrect selection of the catheter was made according to the clinical algorithm.

**Measure:** Complications associated with the use of a peripheral venous catheter

**Time Frame:** Through study completion, an average of 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Admitted to acute care hospital wards.
* Carriers of a peripheral venous catheter.
* With the study evaluation criteria documented in their medical records.

Exclusion Criteria:

* Admitted to gynecology, obstetrics, and pediatrics wards.
* Admitted to the emergency department and intensive care units

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients admitted to some acute care unit requiring peripheral venous catheterization

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** emoreno@csapg.cat

**Name:** Esther Moreno

**Phone:** +34 938960025

**Role:** CONTACT

**Contact 2:**

**Email:** recerca@csapg.cat

**Name:** Noemí Casaponsa

**Phone:** +34 938960025

**Phone Ext:** 43197

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Sant Pere De Ribes

**Contacts:**

***Contact 1:***

- **Email:** emoreno@csapg.cat

- **Name:** Esther Moreno

- **Phone:** +34 938960025

- **Role:** CONTACT

***Contact 2:***

- **Email:** recerca@csapg.cat

- **Name:** Noemí Casaponsa

- **Phone:** +34 938960025

- **Phone Ext:** 43197

- **Role:** CONTACT

***Contact 3:***

- **Name:** Esther Moreno

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Consorci Sanitari Alt Penedes i Garraf

**State:** Barcelona

**Zip:** 08810

#### Overall Officials

**Official 1:**

**Affiliation:** CSAPG

**Name:** Esther Moreno

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

**Description:** IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** After publication of main results of the study.

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
