The Clinical Efficacy of Midline Catheters

The Clinical Efficacy of Midline Catheters for Intravenous Therapy: a Randomized, Controlled Study

The study will evaluate the clinical efficacy of midline catheters compared to conventional treatment in patients with an expected intravenous therapy duration of more than 5 days. Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Endpoints include insertion of CVSs, peripheral venous catheters, catheter patency and a number of possible complications.

Study Overview

• Status: Completed
• Conditions: Intravenous Catheters
• Intervention / Treatment: Device: Midline; Device: PVC and/or PICCline

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Department of Anaesthesiology and Intensive Care East Section, Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Admission to the Department of Infectious Disease or Department of Heart Disease.
• ≥18 years of age
• Expected requirement for iv. therapy >5 days from the day of enrolment as evaluated by a specialist in infectious diseases.
• Mentally competency

Exclusion Criteria:

• Lack of patient consent
• Requirement for a CVC before study eligibility screening or anticipation of an absolute indication for CVC inserted within 24 hours of screening
• Personnel for insertion of midline catheter not available

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Midline; Pt. will receive midline catheters. The outcomes will be registered and some patients will be examined once weekly for thrombosis with ultrasound.	Device: Midline; Pt. will receive midline; Other Names: Powerglide
Active Comparator: Conventional; Pt. will receive the conventional treatment (PVC and/or PICCline/CVC). The outcomes will be registered.	Device: PVC and/or PICCline; Pt. will receive PVC and/or PICCline; Other Names: Conventional catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reducing the use of CVC and PVC	The fraction of patients requiring either a CVC - including PICC line - or require ≥ 4PVC insertions during the current admittance to the hospital, including follow-up intravenous therapy.	through study completion, an average of 7 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bloodsamples from catheter	Registration of number of blood samples taken from the midline catheter	through study completion, an average of 7 month
Problems with catheter bloodsampling	Registration of aspiration problems during bloodsampling in midline catheters	through study completion, an average of 7 month
Bloodsamples (conventional)	Registration of number of blood samples taken from conventional blood samples in both groups	through study completion, an average of 7 month
Patient satisfaction	Patient satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied	through study completion, an average of 7 month
Nurse satisfaction	Nurse satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied	through study completion, an average of 7 month
Painscore	Accumulated NRS pain score for all IV catheter insertions. 0 is no pain and 10 is worst imaginable pain	through study completion, an average of 7 month
Rescue catherizations 1	Rescue PVC's inserted (midline group) (no)	through study completion, an average of 7 month
Rescue catherizations 2	Rescue central venous catheters including PICC line catheters inserted (no)	through study completion, an average of 7 month
Time consumption	Total time of cauterization, (measured from the entrance in patient room, to the exit)	through study completion, an average of 7 month
Catheter dwelltime	Time of catheter duration (hours)	through study completion, an average of 7 month
Fluid	Accumulated fluids infused (L)	through study completion, an average of 7 month
Treatment type	Type of medicine infused (all types)	through study completion, an average of 7 month
Treatment amount	Amount of medicine infused (L)	through study completion, an average of 7 month
Catheter related infections	Catheters removed due to suspected catheter-related infection (no)	through study completion, an average of 7 month
Thrombosis 1	Thrombi visible at the catheter tip (no)	through study completion, an average of 7 month
Thrombosis 2	Deep venous thrombosis of the ipsilateral arm (no)	through study completion, an average of 7 month
Thrombosis 3	Superficial venous thrombosis of the ipsilateral arm (midline group) (no)	through study completion, an average of 7 month
Thrombosis 4	Patients starting anti-thrombotic medicine due to thrombi generated by an IV catheter (no)	through study completion, an average of 7 month
Catheter discontinuation	Reasons for replacing catheters (all types)	through study completion, an average of 7 month
Insertion complication	Arterial punctures during catheter insertions (no)	through study completion, an average of 7 month
Insertion complication 2	haematomas during catheter insertions (no)	through study completion, an average of 7 month
Insertion complication 3	Misplaced catheters (no)	through study completion, an average of 7 month
Neuropraxia	Post-procedure median nerve palsy/neuropraxia (midline group) (no)	through study completion, an average of 7 month

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Emma Bundgaard, MS, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Midline catheter, peripheral venous catheter, central venous catheter, complication rate
• Other Study ID Numbers: midlineivauh18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No