COMPLI-PICC: Study on Picclines' Complications

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: PICC Line Placement

Treatments: Procedure: Piccline

Study type: Observational

Funder types: Other

Identifiers

NCT03017911

COMPLI-PICC

Details and patient eligibility

About

This is a prospective monocentric study of PICC Line complications use in 5 medical and one surgical units of Brest Medical University Hospital.

To evaluate the incidence of the following complications: infections, thromboses, mechanical and hemorrhagic, at month 3 post-intervention.

Also evaluating:

• the management of these PICC Line related complications,
• risk factors for such complications,
• and the mortality-related outcomes.

Full description

All eligible patients fulfilling the inclusion criteria, after PICC Line placement, will receive oral and written patient information describing the study deployment and follow-up. Patients will be followed up until PICC Line removal if it occurs during the first 3 months after placement or until death if it occurs during the first 3 months, or during 3 months in the absence of complications.

• Infectious complications are described in accordance with IDSA 2009 guidelines and include bloodstream infection, endocarditis, local infection and septic thrombophlebitis.
• Thrombotic complications are defined as symptomatic, deep, or superficial venous thrombosis, confirmed by Ultrasound and Echo-Doppler or asymptomatic venous thrombosis diagnosed fortuitously.
• Mechanical complications are defined as impairments related to PICC Line device: occlusion, rupture, accidental removal.
• Hemorrhagic complications are defined as hematoma or bleedings of puncture site.

In the event of PICC Line-related complications, patient will be followed up for an additional 3 months, from the date of complication diagnosis, i.e. maximum follow-up duration of 6 months.

Each week during the first month, then once monthly during the follow-up (i.e. W1, W2, W3, W4, M2, M3, +/- M4, M5, M6), all patients data related to the PICC Line retention or removal, use and all its related complications will be collected.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient > 18 yo
• Patients > 18 yo hospitalized in internal medicine, pneumology, nutrition, oncology, hematology, and cardiac and vascular surgery - who underwent PICC Line placement between October 10, 2016 and March 9, 2017

Exclusion criteria

• Patients hospitalized in other units than those cited above
• Patients verbal refusal to participate in the study

Trial design

120 participants in 1 patient group

Patients with PICC Lines

Description:

All patients included in this study have undergone PICC Line placement before enrollment.

Treatment:

Procedure: Piccline