The Clinical Efficacy of Midline Catheters

Not Applicable

Completed

• Conditions: Intravenous Catheters
• Interventions: Device: PVC and/or PICCline; Device: Midline

• Registration Number: NCT03457259
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-12
• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-07
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	PVC and/or PICCline	Pt. will receive the conventional treatment (PVC and/or PICCline/CVC). The outcomes will be registered.
Midline	Midline	Pt. will receive midline catheters. The outcomes will be registered and some patients will be examined once weekly for thrombosis with ultrasound.

Primary Outcome Measures

Name	Time	Method
Reducing the use of CVC and PVC	through study completion, an average of 7 month	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Care East Section, Aarhus University; 🇩🇰 Aarhus, Denmark