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

Sponsor
Nantes University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04131088
Collaborator
(none)
2,000
1
24.5
81.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Follow up of midlines

Detailed Description

The midline is a deep peripheral venous catheter whose insertion is between the lower and upper third of the arm and whose distal end does not extend beyond the axillary vein. It requires the identification of the vein by ultrasound which reserves its installation for professionals trained and authorized to use the ultrasound scanner.

Midline is currently indicated for intravenous treatments > 7 days and in patients with precarious venous capital. According to the manufacturer's instructions, it can be kept in place for up to 30 days, while the recommendations of the Centers disease of control specify that this period could be extended to 49 days.

Its use is expanding rapidly in France, thus meeting the needs of patients who do not require a central line and whose use of a standard peripheral venous catheter is not possible (low venous capital or treatment duration > 7 days). Its installation, essentially carried out by qualified anaesthetists, does not increase medical planning and is therefore an attractive alternative to the installation of a central catheter whose complications (thrombosis and infections) are known.

The only data on the complication rate, estimated at 1-2%, are from low-potency observational studies. In the absence of high-level evidence, most of the good practice recommendations published in 2019 are based on expert consensus.

This leads us to conduct a large-scale observational study to assess the complication rate and identify the associated factors. This study will provide professionals with reliable scientific data for the next review of good practice recommendations.

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
"Follow-up of Midlines Placed Outside the Intensive Care Unit: What Happens Next, What Side Effects? A Multicenter Observational Study"
Actual Study Start Date :
Dec 18, 2019
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2022

Outcome Measures

Primary Outcome Measures

  1. assess numbers of adverse events [through study completion, an average of 2 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patient

  • No opposition to the study

  • Patient requiring a midline

Exclusion Criteria:
  • 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

  • Refusal of the subject to participate in the study

  • Minor patient;

  • Pregnant woman.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nantes University Hospital Nantes France 44093

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT04131088
Other Study ID Numbers:
  • RC19_0073
First Posted:
Oct 18, 2019
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nantes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2021