Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes

Last updated: May 16, 2024
Sponsor: Hospital de Clinicas de Porto Alegre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Claudication

Vascular Diseases

Blood Clots

Treatment

Subcutaneous tunnelling

Non-tunnelling

Clinical Study ID

NCT06365528
2023-0232
  • Ages > 18
  • All Genders

Study Summary

The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult patients (>= 18 years old) admitted to medical clinics, surgical clinics, orICU, who have an indication for PICC insertion;

Exclusion

Exclusion Criteria:

  • patients with Chronic Kidney Disease, whether dialytic or not;

  • patients in critical or unstable condition characterized by the need for intubation,respiratory rate <8 or >35 breaths per minute, oxygen saturation <90%, heart rate <40 or >140 beats per minute, systolic blood pressure <90mmHg, decreased GlasgowComa Scale >2 points, or prolonged (>5 minutes) or repeated seizures;

  • patients with cognitive deficits that impair their understanding of the study and donot have a responsible party to assist in this stage.

Study Design

Total Participants: 840
Treatment Group(s): 2
Primary Treatment: Subcutaneous tunnelling
Phase:
Study Start date:
May 06, 2024
Estimated Completion Date:
July 31, 2026

Study Description

The data published this year from a multicenter study in Brazil presenting the patterns of use and clinical outcomes of PICC indicated that centers with vascular access teams, adoption of best practices, and current technologies result in low rates of complications, such as primary bloodstream infections related to the catheter, deep vein thrombosis, and reversible occlusion. Despite these more recent data showing that complications related to PICC can be mitigated by the use of technology, vascular access teams, adoption of best practices, and infection control measures, there is still room to incorporate new techniques in PICC insertion with the aim of further reducing avoidable complications. For example, recent studies with robust methodology have demonstrated the benefit of the tunneling technique compared to the conventional insertion technique. A randomized clinical trial showed that the dwell time of the device inserted using the tunneling technique was longer compared to the conventional technique without tunneling in adult patients, along with a lower incidence of thrombosis and infection. At the Hospital de Clínicas de Porto Alegre, recently, nurses from the PICC Team were trained in the tunneling technique at a reference center in Brazil. The initial results of tunneling in adult, pediatric, and neonatal patients are encouraging.

The observed results of implementing the technique indicate that there is potential to reduce avoidable complications and prompt us to propose a multicenter randomized controlled trial involving two additional institutions with similar profiles regarding the composition of Vascular Access Teams, adoption of best practices related to catheter care, and active ongoing education. To our knowledge, robust studies of this nature are not currently being conducted in Brazil.

Connect with a study center

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre,
    Brazil

    Active - Recruiting

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