Clinical trial NCT04155723: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheter-Related Infections
Keywords: Midlines
Lead sponsor: Groupe Hospitalier de Bretagne Sud
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in ICU for more than 48 hours

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.

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

Primary outcomes:
measure: Duration of exposure to central venous catheter
timeFrame: ICU discharge (usually seven days)
Secondary outcomes:
measure: Duration of exposure to peripheral venous catheter
timeFrame: ICU discharge (usually seven days)
measure: Duration of exposure to Midline
timeFrame: ICU discharge (usually seven days)
measure: Number of catheter-related infections
timeFrame: ICU discharge (usually seven days)
measure: Number of catheter-related infections
timeFrame: Hospital discharge (usually two weeks)
measure: Number of catheter-related thrombosis
timeFrame: ICU discharge (usually seven days)
measure: Number of catheter-related thrombosis
timeFrame: Hospital discharge (usually two weeks)
measure: Number of pneumothorax and arterial punctures
timeFrame: ICU discharge (usually seven days)
measure: Number of patients discharged from the ICU with a central venous catheter
timeFrame: ICU discharge (usually seven days)
measure: Description of the events associated with Midlines' insertion : Number of punctures
timeFrame: ICU discharge (usually seven days)
measure: Description of the events associated with Midlines' insertion : Duration of the procedure
timeFrame: ICU discharge (usually seven days)
measure: Description of the events associated with Midlines' insertion : Failure rate
timeFrame: ICU discharge (usually seven days)
Other outcomes:
Locations:
city: Lorient
country: France
facility: Groupe Hospitalier Bretagne Sud
Study officials:
References:
citation: O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
citation: Pathak R, Patel A, Enuh H, Adekunle O, Shrisgantharajah V, Diaz K. The Incidence of Central Line-Associated Bacteremia After the Introduction of Midline Catheters in a Ventilator Unit Population. Infect Dis Clin Pract (Baltim Md). 2015 May;23(3):131-134. doi: 10.1097/IPC.0000000000000237.
citation: Pathak R, Gangina S, Jairam F, Hinton K. A vascular access and midlines program can decrease hospital-acquired central line-associated bloodstream infections and cost to a community-based hospital. Ther Clin Risk Manag. 2018 Aug 21;14:1453-1456. doi: 10.2147/TCRM.S171748. eCollection 2018.
citation: Xu T, Kingsley L, DiNucci S, Messer G, Jeong JH, Morgan B, Shutt K, Yassin MH. Safety and utilization of peripherally inserted central catheters versus midline catheters at a large academic medical center. Am J Infect Control. 2016 Dec 1;44(12):1458-1461. doi: 10.1016/j.ajic.2016.09.010.
citation: Shokoohi H, Boniface K, McCarthy M, Khedir Al-tiae T, Sattarian M, Ding R, Liu YT, Pourmand A, Schoenfeld E, Scott J, Shesser R, Yadav K. Ultrasound-guided peripheral intravenous access program is associated with a marked reduction in central venous catheter use in noncritically ill emergency department patients. Ann Emerg Med. 2013 Feb;61(2):198-203. doi: 10.1016/j.annemergmed.2012.09.016. Epub 2012 Nov 7.
citation: Alexandrou E, Spencer TR, Frost SA, Mifflin N, Davidson PM, Hillman KM. Central venous catheter placement by advanced practice nurses demonstrates low procedural complication and infection rates--a report from 13 years of service*. Crit Care Med. 2014 Mar;42(3):536-43. doi: 10.1097/CCM.0b013e3182a667f0.