- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05264402
Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS (PICCORMID)
A long-term venous access is frequently required in patient management. Currently, it is ensured by using the long peripheral intravenous catheters (Midline) or peripheral inserted central catheters (PICC line). Either is inserted into a peripheral vein of the upper arm and extends to the distal axillary vein.
If the indications for the two catheters can sometimes be debated, the Midline catheter seems to be more and more used. The complications related to the use of PICC lines have been well described in literature, whereas the comparison of the two catheter-related complications has been less analysed.
The aim of this study is to compare the incidences of catheter-related bloodstream infections linked to PICCs and Midlines.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
This single-center observational study will record and compare Midline and PICC line catheter-related bloodstream infections in the first 30 days after placement, catheter-related bloodstream infections being defined as clinical signs associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points.
Catheter indications, insertion conditions, incidence of haemorrhagic and thrombotic complications during the first 30 days will be analyzed.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: AnaÏS CAILLARD
- Telefonnummer: 02 98 34 72 88
- E-post: anais.caillard@chu-brest.fr
Studera Kontakt Backup
- Namn: Brigitte HUIBAN
- E-post: brigitte.huiban@chu-brest.fr
Studieorter
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Brest, Frankrike, 29609
- Rekrytering
- CHRU de Brest
-
Kontakt:
- Anais CAILLARD
- E-post: anais.caillard@chu-brest.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Major ≥ 18 years old
- opposition formulated
Exclusion Criteria:
- Refusal of participation
- Patients under legal protection (guardianship, curatorship, etc.)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
PICCline group
Patients needing a vascular approach using PICCline catheters
|
|
Midline group
Patients needing a vascular approach using Midline catheters
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Compared rate of catheter-related bloodstream infections in the first 30 days in Midline and PICCline group. Catheter-related bloodstream infections are defined as clinical signs with a positive catheter culture without any other infectious entry points.
Tidsram: first 30 days after placement
|
catheter-related bloodstream infections being defined as clinical signs (fever, swelling, pain) associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points. the number of infections recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline |
first 30 days after placement
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
catheter placement time will be evaluated in days
Tidsram: first 30 days after placement
|
catheter placement time will be evaluted by measuring the time between catheter placement and removal in days
|
first 30 days after placement
|
|
rate of no infection complications like obstruction, accidental removal, thrombosis, hemorrhagic complications
Tidsram: first 30 days
|
The number of mechanical compliaction (obstruction, accidental removal, etc.), haemorrhagic and thrombotic complications recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline
|
first 30 days
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PICCORMID (29BRC21.0288)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
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