Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS

NCT05264402 | Unknown

• 1 other identifier: PICCORMID (29BRC21.0288)
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

A long-term venous access is frequently required in patient management. Currently, it is ensured by using the long peripheral intravenous catheters (Midline) or peripheral inserted central catheters (PICC line). Either is inserted into a peripheral vein of the upper arm and extends to the distal axillary vein. If the indications for the two catheters can sometimes be debated, the Midline catheter seems to be more and more used. The complications related to the use of PICC lines have been well described in literature, whereas the comparison of the two catheter-related complications has been less analysed. The aim of this study is to compare the incidences of catheter-related bloodstream infections linked to PICCs and Midlines.

Conditions

Catheter-related Bloodstream Infection

Keywords

venous access; Midline; PICC line; catheter-related bloodstream infections

Outcome Measures

Primary Outcomes (1)

• Compared rate of catheter-related bloodstream infections in the first 30 days in Midline and PICCline group. Catheter-related bloodstream infections are defined as clinical signs with a positive catheter culture without any other infectious entry points.

  catheter-related bloodstream infections being defined as clinical signs (fever, swelling, pain) associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points. the number of infections recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline

  first 30 days after placement

Secondary Outcomes (2)

• catheter placement time will be evaluated in days

  first 30 days after placement

• rate of no infection complications like obstruction, accidental removal, thrombosis, hemorrhagic complications

  first 30 days

Study Arms (2)

PICCline group

Patients needing a vascular approach using PICCline catheters

Midline group

Patients needing a vascular approach using Midline catheters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a vascular approach using PICCline or Midline catheters

You may qualify if:

• Major ≥ 18 years old
• opposition formulated

You may not qualify if:

• Refusal of participation
• Patients under legal protection (guardianship, curatorship, etc.)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

Central Study Contacts

AnaÏS CAILLARD

CONTACT

02 98 34 72 88; anais.caillard@chu-brest.fr

Brigitte HUIBAN

CONTACT

brigitte.huiban@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: March 3, 2022
• Study Start: November 15, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning one year and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)