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

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ClinicalTrials.gov Identifier: NCT04155723
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Pierre Bouju, Groupe Hospitalier de Bretagne Sud

Brief Summary:

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.


Condition or disease
Catheter-Related Infections

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 356 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of a Task Delegation to ICU Nurses for Midlines' Placement on the Duration of Exposure to Central Venous Catheters
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : August 1, 2021

Group/Cohort
Phase 1 group
During phase 1, Midlines are inserted only by doctors.
Phase 2 group
During Phase 2, Midlines are preferentially inserted by ICU nurses, and if needed, by doctors.



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in ICU for more than 48 hours
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155723


Contacts
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Contact: Pierre Bouju, MD + 33 2 97 06 92 11 p.bouju@ghbs.bzh

Locations
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France
Groupe Hospitalier Bretagne Sud Recruiting
Lorient, France, 56100
Contact: Pierre Bouju, MD    02 97 06 92 11    p.bouju@ghbs.bzh   
Sponsors and Collaborators
Groupe Hospitalier de Bretagne Sud
Publications:

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Responsible Party: Pierre Bouju, Principal Investigator, Groupe Hospitalier de Bretagne Sud
ClinicalTrials.gov Identifier: NCT04155723    
Other Study ID Numbers: GHBretagneSud
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pierre Bouju, Groupe Hospitalier de Bretagne Sud:
Midlines
Additional relevant MeSH terms:
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Catheter-Related Infections
Infection