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

NCT06365528 | Recruiting

• 1 other identifier: 2023-0232
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

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.

Conditions

CLABSI - Central Line Associated Bloodstream Infection; Deep Vein Thrombosis; Dislodged Catheter; Occlusion; Catheter Rupture; Catheter (Other); Complications

Outcome Measures

Primary Outcomes (1)

• End of therapy or catheter removal free from complications

  Time in days

  Up to 30 days

Study Arms (2)

Tunneled PICC

EXPERIMENTAL

The intervention group will consist of adult patients who will have PICCs inserted using the catheter tunneling technique. The technique involves the catheter being exteriorized through the skin at a site different from the blood vessel puncture site, thus traversing a subcutaneous tunnel.

Procedure: Subcutaneous tunnelling

Non-tunneled PICC

ACTIVE COMPARATOR

The control group will consist of adults patients who will have PICCs inserted using the conventional technique

Procedure: Non-tunnelling

Interventions

Subcutaneous tunnelling PROCEDURE

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.

Tunneled PICC

Non-tunnelling PROCEDURE

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.

Non-tunneled PICC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Hospital Moinhos de Vento: collaborator
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis; Bites and Stings

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Eneida R Rabelo da Silva, ScD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eneida R Rabelo da Silva, ScD

CONTACT

5551998068616; eneidarabelo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Prospective Randomized Open, Blinded End-point (PROBE Study)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: May 6, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)