Central Venous Catheter, Vascular Access Devices
Conditions
Keywords
Peripherally Inserted Central Catheter Line Insertion, Catheterization, Peripheral Venous
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.
Interventions
DEVICEBard PowerPICC
PICC Insertion
DEVICEBard PowerMidline catheter
Midline Insertion
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of patients without VAD-related adverse event requiring medical intervention | Until 1 week after VAD retrieval | Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death |
| % 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
| Measure | Time frame | Description |
|---|---|---|
| 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 experience VAD-related adverse events requiring medical intervention | Until 1 week after VAD retrieval | Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death |
| % 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 | — |
| % 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 | — |
| Number of VAD-related adverse events requiring medical intervention per 1000 catheter/days | Until 1 week after VAD retrieval | — |
Countries
Canada
Outcome results
None listed