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Completed

NCT Number: NCT03457259

The Clinical Efficacy of Midline Catheters

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.

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Key information

Conditions

Intravenous Catheters

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Intensive Care East Section, Aarhus University

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVC and/or PICCline

Device

Pt. will receive PVC and/or PICCline

Other names: Conventional catheterization

Midline

Device

Pt. will receive midline

Other names: Powerglide

Primary outcomes

  1. Reducing the use of CVC and PVC

    Time frame: 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 outcomes

  1. Bloodsamples from catheter

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

    Registration of number of blood samples taken from the midline catheter

  2. Problems with catheter bloodsampling

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

    Registration of aspiration problems during bloodsampling in midline catheters

  3. Bloodsamples (conventional)

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

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

  4. Patient satisfaction

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

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

  5. Nurse satisfaction

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

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

  6. Painscore

    Time frame: 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

  7. Rescue catherizations 1

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

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

  8. Rescue catherizations 2

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

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

  9. Time consumption

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

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

  10. Catheter dwelltime

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

    Time of catheter duration (hours)

  11. Fluid

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

    Accumulated fluids infused (L)

  12. Treatment type

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

    Type of medicine infused (all types)

  13. Treatment amount

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

    Amount of medicine infused (L)

  14. Catheter related infections

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

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

  15. Thrombosis 1

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

    Thrombi visible at the catheter tip (no)

  16. Thrombosis 2

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

    Deep venous thrombosis of the ipsilateral arm (no)

  17. Thrombosis 3

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

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

  18. Thrombosis 4

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

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

  19. Catheter discontinuation

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

    Reasons for replacing catheters (all types)

  20. Insertion complication

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

    Arterial punctures during catheter insertions (no)

  21. Insertion complication 2

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

    haematomas during catheter insertions (no)

  22. Insertion complication 3

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

    Misplaced catheters (no)

  23. Neuropraxia

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

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2018
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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