Clinical trial NCT06365528: Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes
Official title: Tunneled Versus Non-Tunneled Peripherally Inserted Central Catheter and Their Effects on Reducing Combined or Isolated Outcomes (Obstruction, Infection, Thrombosis, and Dislodgement): Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CLABSI - Central Line Associated Bloodstream Infection
Deep Vein Thrombosis
Dislodged Catheter
Occlusion
Catheter Rupture
Catheter (Other); Complications
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Hospital Moinhos de Vento
name: Irmandade Santa Casa de Misericórdia de Porto Alegre
First posted: 2024-04-15
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* adult patients (\>= 18 years old) admitted to medical clinics, surgical clinics, or ICU, who have an indication for PICC insertion;

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 Glasgow Coma Scale \>2 points, or prolonged (\>5 minutes) or repeated seizures;
* patients with cognitive deficits that impair their understanding of the study and do not have a responsible party to assist in this stage.

Primary outcomes:
measure: End of therapy or catheter removal free from complications
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Eneida R Rabelo da Silva, ScD
role: PRINCIPAL_INVESTIGATOR
References: