RECRUITINGINTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - adult patients (\>= 18 years old) admitted to medical clinics, surgical clinics, or ICU, who have an indication for PICC insertion; Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

PROCEDURE

Subcutaneous tunnelling

The Subcutaneous tunnelling group will undergo PICC placement under ultrasonography. Procedures will be implemented under hand hygiene, maximal sterile barrier, and chlorhexidine. The targeted arm will be sterilized with a mixture of chlorhexidine and isopropyl alcohol, and a sterile drape will be placed to cover the entire procedure feld from head to toe and place with additional subcutaneous tunnelling. After vein puncture with the access needle, a Nitinol guidewire will be placed as usual. We will make a tunnel distal to the initial venepuncture site using an additional 14-gauge needle. After resolution of the loop over the venepuncture site, a peel-away sheath will be placed over the wire. The catheter will be trimmed to the distance between the venepuncture site and cavoatrial junction plus the subcutaneous tunnel before being inserted in the usual manner.

PROCEDURE

Non-tunnelling

The Non-tunnelling group will have PICC placement with the traditional method under ultrasonography. Procedures will be implemented under hand hygiene, maximal sterile barrier, and chlorhexidine. The targeted arm will be sterilized with a mixture of chlorhexidine and isopropyl alcohol, and a sterile drape will be placed to cover the entire procedure feld from head to toe. After vein puncture with the access needle, a Nitinol guidewire will be placed. After, a peel-away sheath will be placed over the wire. The catheter will be trimmed to the distance between the venepuncture site and cavoatrial junction.

Locations (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil