Safety and Efficacy of Midline and PICC

NCT ID: NCT03502980

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 293 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2022-07-21

Brief Summary

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.

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.

Conditions

Vascular Access Devices; Central Venous Catheter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Peripherally inserted central venous catheters

Bard PowerPICC

Group Type: ACTIVE_COMPARATOR

Bard PowerPICC

Intervention Type: DEVICE

PICC Insertion

Midline

Bard PowerMidline catheter

Group Type: ACTIVE_COMPARATOR

Bard PowerMidline catheter

Intervention Type: DEVICE

Midline Insertion

Interventions

Bard PowerPICC

PICC Insertion

Intervention Type: DEVICE

Bard PowerMidline catheter

Midline Insertion

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Éric Thérasse, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre hospitalier de l'université de Montréal

Montreal, Quebec, Canada

Countries

Canada

References

Bentridi A, Giroux MF, Soulez G, Bouchard L, Perreault P, Chouinard A, Dorais M, Do Amaral R, Bernier P, Therasse E. Midline Venous Catheter vs Peripherally Inserted Central Catheter for Intravenous Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e251258. doi: 10.1001/jamanetworkopen.2025.1258.

Reference Type: DERIVED

PMID: 40111366 (View on PubMed)

Other Identifiers

7749

Identifier Type: -

Identifier Source: org_study_id