Safety and Efficacy of Midline and PICC (MidLine_PICC)

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

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.

Study Overview

• Status: Completed
• Conditions: Central Venous Catheter; Vascular Access Devices
• Intervention / Treatment: Device: Bard PowerPICC; Device: Bard PowerMidline catheter

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 293
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peripherally inserted central venous catheters; Bard PowerPICC	Device: Bard PowerPICC; PICC Insertion
Active Comparator: Midline; Bard PowerMidline catheter	Device: Bard PowerMidline catheter; Midline Insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of patients without VAD-related adverse event requiring medical intervention	Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death	Until 1 week after VAD retrieval
% 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)		Until 1 week after VAD retrieval

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of patients who experience VAD-related adverse events requiring medical intervention	Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death	Until 1 week after VAD retrieval
Number of VAD-related adverse events requiring medical intervention per 1000 catheter/days		Until 1 week after VAD retrieval
Time to first VAD-related adverse events		Until 1 week after VAD retrieval
Duration VAD intervention (Midline or PICC)		Index procedure
Number of additional interventions to insert the VAD		Index procedure
% of patients who required another VAD to complete the intended or additional iv treatments, either because of VAD complications, dysfunctions or limitations		Until 1 week after VAD retrieval
% of patient without failed blood sampling attempts through the VAD		Until 1 week after VAD retrieval
% of patients for whom the end of treatment was the reason for VAD retrieval		Until 1 week after VAD retrieval

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Éric Therasse, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): July 21, 2022

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Peripherally Inserted Central Catheter Line Insertion; Catheterization, Peripheral Venous
• Other Study ID Numbers: 7749

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No