CClinicalTrials.gg
CompletedNCT03457259Updated Apr 7, 2020

The Clinical Efficacy of Midline Catheters

An interventional study of PVC and/or PICCline and Midline in Intravenous Catheters, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-07.

Sponsored by University of Aarhus · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Intravenous Catheters

Keywords

  • Midline catheter, peripheral venous catheter, central venous catheter, complication rate
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • 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

  • Active comparator
    Conventional

    Pt. will receive the conventional treatment (PVC and/or PICCline/CVC). The outcomes will be registered.

    Device: PVC and/or PICCline

Interventions

  • DevicePVC and/or PICCline

    Pt. will receive PVC and/or PICCline

    Also known as: Conventional catheterization

  • DeviceMidline

    Pt. will receive midline

    Also known as: Powerglide

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 7 month

Secondary outcomes

  1. Bloodsamples from catheter

    Registration of number of blood samples taken from the midline catheter

    Time frame: through study completion, an average of 7 month

  2. Problems with catheter bloodsampling

    Registration of aspiration problems during bloodsampling in midline catheters

    Time frame: through study completion, an average of 7 month

  3. Bloodsamples (conventional)

    Registration of number of blood samples taken from conventional blood samples in both groups

    Time frame: through study completion, an average of 7 month

  4. Patient satisfaction

    Patient satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied

    Time frame: through study completion, an average of 7 month

  5. Nurse satisfaction

    Nurse satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied

    Time frame: through study completion, an average of 7 month

  6. Painscore

    Accumulated NRS pain score for all IV catheter insertions. 0 is no pain and 10 is worst imaginable pain

    Time frame: through study completion, an average of 7 month

  7. Rescue catherizations 1

    Rescue PVC's inserted (midline group) (no)

    Time frame: through study completion, an average of 7 month

  8. Rescue catherizations 2

    Rescue central venous catheters including PICC line catheters inserted (no)

    Time frame: through study completion, an average of 7 month

  9. Time consumption

    Total time of cauterization, (measured from the entrance in patient room, to the exit)

    Time frame: through study completion, an average of 7 month

  10. Catheter dwelltime

    Time of catheter duration (hours)

    Time frame: through study completion, an average of 7 month

  11. Fluid

    Accumulated fluids infused (L)

    Time frame: through study completion, an average of 7 month

  12. Treatment type

    Type of medicine infused (all types)

    Time frame: through study completion, an average of 7 month

  13. Treatment amount

    Amount of medicine infused (L)

    Time frame: through study completion, an average of 7 month

  14. Catheter related infections

    Catheters removed due to suspected catheter-related infection (no)

    Time frame: through study completion, an average of 7 month

  15. Thrombosis 1

    Thrombi visible at the catheter tip (no)

    Time frame: through study completion, an average of 7 month

  16. Thrombosis 2

    Deep venous thrombosis of the ipsilateral arm (no)

    Time frame: through study completion, an average of 7 month

  17. Thrombosis 3

    Superficial venous thrombosis of the ipsilateral arm (midline group) (no)

    Time frame: through study completion, an average of 7 month

  18. Thrombosis 4

    Patients starting anti-thrombotic medicine due to thrombi generated by an IV catheter (no)

    Time frame: through study completion, an average of 7 month

  19. Catheter discontinuation

    Reasons for replacing catheters (all types)

    Time frame: through study completion, an average of 7 month

  20. Insertion complication

    Arterial punctures during catheter insertions (no)

    Time frame: through study completion, an average of 7 month

  21. Insertion complication 2

    haematomas during catheter insertions (no)

    Time frame: through study completion, an average of 7 month

  22. Insertion complication 3

    Misplaced catheters (no)

    Time frame: through study completion, an average of 7 month

  23. Neuropraxia

    Post-procedure median nerve palsy/neuropraxia (midline group) (no)

    Time frame: through study completion, an average of 7 month

06

Study locations

1 site
  • Department of Anaesthesiology and Intensive Care East Section, Aarhus University
    Aarhus, 8000, Denmark
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03457259
Lead sponsor
University of Aarhus
Responsible party
Emma Bundgaard Nielsen (Medical student, Research student, University of Aarhus) — Principal investigator
First posted
Mar 7, 2018
Start date
Feb 12, 2018
Primary completion
Jul 30, 2019
Completion
Jul 30, 2019
Last update
Apr 7, 2020

Study contacts

Emma Bundgaard, MS
principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion