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Safety and Efficacy of Midline and PICC (MidLine_PICC)

C

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Completed

Conditions

Vascular Access Devices
Central Venous Catheter

Treatments

Device: Bard PowerMidline catheter
Device: Bard PowerPICC

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.

Full description

Vascular access devices (VADs), including peripherally inserted central venous catheters (PICCs) remain a cornerstone for the delivery of necessary intravenous therapy. PICCs are being selected for venous access more frequently today than ever before.

The advantage of PICC is that it can be used for all intravenous therapy. However, PICC requires the use of fluoroscopy or other type of guidance which add to the cost and time required to insert the catheter. Midline, on the other hand, can be inserted under ultrasound guidance, takes less time to be inserted and cost less than PICC insertion.

Despite lower cost and better accessibility of midline in comparison with PICC for non-vesicant intravenous therapy, there is very little evidence in the literature to suggest that one type of venous access is better than the other.

The primary objective of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.

Results of this trial will allow improving a quality of evidence for using midline instead of PICC for specified indications. If Midline are non-inferior for some indications, they would represent a more accessible and less expensive alternative than PICC insertion.

Enrollment

293 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Required intra venous therapy
  • Expected duration of the venous access: > 6 days and < 30days

Exclusion criteria

  • Patient has a contraindication to insertion of either a Midline or a PICC relative to the therapy
  • Patient from other hospitals who come to the CHUM only for the installation of a central line
  • Decreased cognitive ability to care for device at home
  • Preexisting bacteremia (ie, existing positive blood cultures that had not been repeated with negative results)
  • Preexisting venous thrombosis or known hypercoagulable states (such as protein C or S deficiency, antithrombin deficiency, lupus anticoagulant)
  • Venous access with multiple lumens required
  • Patients not able to give informed consent
  • Prior participation to this study
  • Patient is enrolled in another investigational study
  • Patients hospitalized in the intensive care unit
  • Patients who are difficult to puncture and require multiple blood samples

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

293 participants in 2 patient groups

Peripherally inserted central venous catheters
Active Comparator group
Description:
Bard PowerPICC
Treatment:
Device: Bard PowerPICC
Midline
Active Comparator group
Description:
Bard PowerMidline catheter
Treatment:
Device: Bard PowerMidline catheter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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