"Follow-up of Midlines Placed Outside the Intensive Care Unit: What Side Effects? An Observational Study"

NCT04131088 | Completed

• 1 other identifier: RC19_0073
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Midline catheter is a peripherally-inserted catheter, with the distal tip being placed into the axillary vein. For some indications, it's an alternative to the peripheral insert central catheters in case of limited venous access and infusions less than one month. The Midline catheter is poorly described in scientific literature; therefore, the aim of the study is to determinate the incidence of adverse events (Infections and thrombosis) and risk factors for patients with this device.

Conditions

Thrombosis

Keywords

Midline catheter; adverse event; catheter-related bloodstream infections; thrombosis

Outcome Measures

Primary Outcomes (1)

• assess numbers of adverse events

  catheter related infection yes/no vein thrombosis yes/no occlusion yes/no exposition time to a midline catheter

  through study completion, an average of 2 year

Interventions

Follow up of midlines OTHER

The follow-up data to be collected will be recorded on a monitoring logbook that will follow the patient (Appendix 4). The latter will be involved in the follow-up of his data insofar as he will be able to solicit the various professionals performing care on his midline in order to aim at the exhaustiveness of the filling of the book.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients concerned with this study requiring a midline for any indication and hospitalized in a department other than intensive care or intensive care.

You may qualify if:

• Adult patient
• No opposition to the study
• Patient requiring a midline

You may not qualify if:

• Patient in Intensive Care Unit or acute care unit.
• Patient with a contra indication to midline insertion: arterio-venous fistula, history of axillary lymph node clearance or radiotherapy in the infusion arm, presence of infectious skin lesions near the infusion area, presence of a prosthesis on the infusion arm or hemiplegic arm.
• Patient under legal protection measure
• Patient already enrolled
• Minor patient;
• Pregnant woman.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Related Publications (1)

• Derouin Y, Le Thuaut A, Dauvergne J, Cinotti R, Cartron E. Complications and risk factors on midline catheters' follow-up about non-ICU patients: study protocol for a multicentre observational study (the midDATA study). BMJ Open. 2023 Jul 18;13(7):e067796. doi: 10.1136/bmjopen-2022-067796.

  PMID: 37463802 DERIVED

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: December 23, 2019
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: June 27, 2023

Record last verified: 2021-09

Locations

FR (1)