COMPLI-PICC: Study on Picclines' Complications

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-10

Study Completion Date

2017-05-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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PICC Line Placement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with PICC Lines

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

Piccline

Intervention Type PROCEDURE

Interventions

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Piccline

Intervention Type PROCEDURE

Eligibility Criteria

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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