Actively Recruiting
Led by Hospital de Clinicas de Porto Alegre · Updated on 2024-05-20
840
Participants Needed
1
Research Sites
30 weeks
Total Duration
H
Hospital de Clinicas de Porto Alegre
Lead Sponsor
H
Hospital Moinhos de Vento
Collaborating Sponsor
Researchers are evaluating the use of tunneled versus non-tunneled peripherally inserted central catheters (PICCs) in adults to compare their effects on complications such as bloodstream infections, thrombosis, obstruction, and accidental dislodgement. This multicenter randomized clinical trial aims to determine if the tunneling technique can reduce these complications better than the conventional insertion method within a 30-day period. The study is motivated by recent findings suggesting that the tunneling technique may increase catheter dwell time and lower complication rates, with initial encouraging results at a reference hospital in Brazil. The study involves two groups: one receiving PICCs inserted using the catheter tunneling technique, where the catheter passes through a subcutaneous tunnel before exiting the skin at a different site from the vein puncture, and the other receiving PICCs inserted by the conventional non-tunneled method. Both procedures are performed under ultrasonography guidance and strict sterile conditions, including hand hygiene and chlorhexidine antisepsis. The tunneled method includes creating a subcutaneous tunnel with an additional needle before inserting the catheter, while the conventional group follows the standard insertion without tunneling. Participants are adult patients admitted to medical, surgical clinics, or intensive care units who require PICC insertion. Researchers will monitor the participants for up to 30 days, assessing catheter-related complications and catheter removal free from issues. The study includes ongoing education and best practices for catheter care, with outcomes focused on infection, thrombosis, obstruction, and dislodgement rates. Safety and effectiveness of each technique will be evaluated through clinical follow-up during this period, with data collected from multiple centers.
CONDITIONS
Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days or until catheter removal
Participants will have a Peripherally Inserted Central Catheter (PICC) placed using either the tunneling technique or the conventional non-tunneling technique.
Visits as needed for catheter care and monitoring during therapy
Duration - Up to 30 days after catheter removal
Participants are monitored for complications such as obstruction, infection, thrombosis, and dislodgement after PICC placement.
Follow-up visits as needed to assess outcomes
Total: 1 location
1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Actively Recruiting
E
Eneida R Rabelo da Silva, ScD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Rodrigo do Nascimento Ceratti, Knut Taxbro, Vineet Chopra...
https://pubmed.ncbi.nlm.nih.gov/41805752