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Completed

NCT Number: NCT03502980

Safety and Efficacy of Midline and PICC

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.

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Key information

Conditions

Vascular Access Devices Central Venous Catheter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier de l'université de Montréal

Montreal, Quebec, H2X 3E4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bard PowerPICC

Device

PICC Insertion

Bard PowerMidline catheter

Device

Midline Insertion

Primary outcomes

  1. % of patients without VAD-related adverse event requiring medical intervention

    Time frame: Until 1 week after VAD retrieval

    Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death

  2. % of patients whose intended or additional I.V treatments could be completed with the VAD without VAD complications, dysfunctions or limitations (ex: need for central access or for additional peripheral or central lumens/catheters)

    Time frame: Until 1 week after VAD retrieval

Secondary outcomes

  1. % of patients who experience VAD-related adverse events requiring medical intervention

    Time frame: Until 1 week after VAD retrieval

    Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death

  2. Number of VAD-related adverse events requiring medical intervention per 1000 catheter/days

    Time frame: Until 1 week after VAD retrieval

  3. Time to first VAD-related adverse events

    Time frame: Until 1 week after VAD retrieval

  4. Duration VAD intervention (Midline or PICC)

    Time frame: Index procedure

  5. Number of additional interventions to insert the VAD

    Time frame: Index procedure

  6. % of patients who required another VAD to complete the intended or additional iv treatments, either because of VAD complications, dysfunctions or limitations

    Time frame: Until 1 week after VAD retrieval

  7. % of patient without failed blood sampling attempts through the VAD

    Time frame: Until 1 week after VAD retrieval

  8. % of patients for whom the end of treatment was the reason for VAD retrieval

    Time frame: Until 1 week after VAD retrieval

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

Safety and Efficacy of Midline and Peripherally Inserted Central Catheter for Intravenous Therapy: a Randomized Controlled Trial

Acronym: MidLine_PICC

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2018
Registry last updated
Jul 25, 2022

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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