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Completed

NCT Number: NCT04155723

Impact of a Task Delegation to ICU Nurses for Midlines' Placement

The administration of medication, fluid resuscitation, or even nutrition in intensive care unit (ICU) patients, requires one or more infusion lines which can be peripheral or central. Midline catheter is a 10 to 20 cm long peripheral venous catheter, which can be used for up to 28 days. These features make it a good alternative to central venous and conventional peripheral venous catheters.

Midlines are routinely used in the ICU of Lorient Hospital, currently inserted by doctors. In association with the Regional Health Agency, the investigators are currently implementing a project of task delegation to ICU nurses, so that they could insert Midlines' catheters. The aim of the study is to increase the use of Midlines in the unit to reduce the exposure to central venous catheters and their complications, such as infections or thrombosis.

The investigators propose to conduct a prospective monocentric study to compare the frequency of Midlines'use, before and after the task delegation. The primary objective is to compare the duration of exposure to central venous catheters between the two periods. Secondary objectives are to compare the duration of exposure to peripheral venous catheters and Midlines, and the catheter-related infections and thrombosis.

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Key information

Conditions

Catheter-Related Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Bretagne Sud

Lorient, 56100, France

About this study

The administration of medication, fluid resuscitation, or even nutrition in intensive care unit (ICU) patients, requires one or more infusion lines which can be peripheral or central. Although central venous catheters (CVC) are often mandatory in ICU, the risk of catheter-related infections should lead to consider the insertion of peripheral venous catheters. However in ICU patients, presence of edema or poor venous condition may not allow placement of peripheral venous catheter.

Midline catheter is a 10 to 20 cm long peripheral venous catheter, which can be used for up to 28 days (according to manufacturer recommendations). These features make it a good alternative to central venous and conventional peripheral venous catheters. They are placed at the bedside, peripherally into the cephalic or basilic vein, with the tip reaching the axillary vein.

Midlines are routinely used in the ICU of Lorient Hospital, currently inserted by doctors. Studies have shown the feasibility and the safety of delegating to nurses placement of CVC and Midlines. In association with the Regional Health Agency, the investigators are currently implementing a project of task delegation to ICU nurses, so that they could insert Midlines' catheters.

Midlines' implementation has been associated with a decrease in the use of CVC and catheter-related infections. To our knowledge, no study investigated the placement of Midlines by nurses in the ICU.

The investigators propose to conduct a prospective monocentric study to compare the frequency of Midlines' use, before and after the task delegation. The primary objective is to compare the duration of exposure to central venous catheters between the two periods. Secondary objectives are to compare the duration of exposure to peripheral venous catheters and Midlines, and the catheter-related infections and thrombosis. Complications related to Midlines' placement would also be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients hospitalized in ICU for more than 48 hours

Exclusion criteria

  • Patient under 18 years old
  • Patient under legal guardianship
  • Absence of health insurance in France
  • Refusal of the patient or his next-of-kin
  • Patient with a decision of withholding or withdrawing of life sustaining therapy
  • Patient with a subcutaneous central venous port
  • Impossibility of infusion on the upper limbs

Treatment and study plan

Primary outcomes

  1. Duration of exposure to central venous catheter

    Time frame: ICU discharge (usually seven days)

    Duration of exposure to central venous catheter (catheter-days per patient-day)

Secondary outcomes

  1. Duration of exposure to peripheral venous catheter

    Time frame: ICU discharge (usually seven days)

    Duration of exposure to peripheral venous catheter (catheter-days per patient-day)

  2. Duration of exposure to Midline

    Time frame: ICU discharge (usually seven days)

    Duration of exposure to Midline (catheter-days per patient-day)

  3. Number of catheter-related infections

    Time frame: ICU discharge (usually seven days)

    Number of catheter-related infections (number of events per 1000 catheter days)

  4. Number of catheter-related infections

    Time frame: Hospital discharge (usually two weeks)

    Number of catheter-related infections (number of events per 1000 catheter days)

  5. Number of catheter-related thrombosis

    Time frame: ICU discharge (usually seven days)

    Number of catheter-related thrombosis (number of events per 1000 catheter days)

  6. Number of catheter-related thrombosis

    Time frame: Hospital discharge (usually two weeks)

    Number of catheter-related thrombosis (number of events per 1000 catheter days)

  7. Number of pneumothorax and arterial punctures

    Time frame: ICU discharge (usually seven days)

    Number of pneumothorax and arterial punctures (for each catheter inserted, percentage)

  8. Number of patients discharged from the ICU with a central venous catheter

    Time frame: ICU discharge (usually seven days)

    Number of patients discharged from the ICU with a central venous catheter (percentage)

  9. Description of the events associated with Midlines' insertion : Number of punctures

    Time frame: ICU discharge (usually seven days)

    Number of punctures (per Midline inserted)

  10. Description of the events associated with Midlines' insertion : Duration of the procedure

    Time frame: ICU discharge (usually seven days)

    Duration of the procedure (in minutes)

  11. Description of the events associated with Midlines' insertion : Failure rate

    Time frame: ICU discharge (usually seven days)

    Failure rate (percentage)

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de Bretagne Sud

Other

Registry information

Official study title

Impact of a Task Delegation to ICU Nurses for Midlines' Placement on the Duration of Exposure to Central Venous Catheters

Acronym: IDEM

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 7, 2019
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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