Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 25, 2019
First Posted Date November 7, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date November 6, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2019)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 5, 2019)
  • 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)
  • Duration of exposure to Midline [ Time Frame: ICU discharge (usually seven days) ]
    Duration of exposure to Midline (catheter-days per patient-day)
  • Number of catheter-related infections [ Time Frame: ICU discharge (usually seven days) ]
    Number of catheter-related infections (number of events per 1000 catheter days)
  • Number of catheter-related infections [ Time Frame: Hospital discharge (usually two weeks) ]
    Number of catheter-related infections (number of events per 1000 catheter days)
  • Number of catheter-related thrombosis [ Time Frame: ICU discharge (usually seven days) ]
    Number of catheter-related thrombosis (number of events per 1000 catheter days)
  • Number of catheter-related thrombosis [ Time Frame: Hospital discharge (usually two weeks) ]
    Number of catheter-related thrombosis (number of events per 1000 catheter days)
  • Number of pneumothorax and arterial punctures [ Time Frame: ICU discharge (usually seven days) ]
    Number of pneumothorax and arterial punctures (for each catheter inserted, percentage)
  • 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)
  • Description of the events associated with Midlines' insertion : Number of punctures [ Time Frame: ICU discharge (usually seven days) ]
    Number of punctures (per Midline inserted)
  • 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)
  • Description of the events associated with Midlines' insertion : Failure rate [ Time Frame: ICU discharge (usually seven days) ]
    Failure rate (percentage)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of a Task Delegation to ICU Nurses for Midlines' Placement
Official Title Impact of a Task Delegation to ICU Nurses for Midlines' Placement on the Duration of Exposure to Central Venous Catheters
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.

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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients hospitalized in ICU for more than 48 hours
Condition Catheter-Related Infections
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 5, 2019)
356
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pierre Bouju, MD + 33 2 97 06 92 11 p.bouju@ghbs.bzh
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04155723
Other Study ID Numbers GHBretagneSud
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Pierre Bouju, Groupe Hospitalier de Bretagne Sud
Study Sponsor Groupe Hospitalier de Bretagne Sud
Collaborators Not Provided
Investigators Not Provided
PRS Account Groupe Hospitalier de Bretagne Sud
Verification Date November 2019