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NCT Number: NCT06365528

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Location status: Recruiting

Location contact

Eneida R Rabelo da Silva, ScD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. End of therapy or catheter removal free from complications

    Time frame: Up to 30 days

    Time in days

Study contacts

Contact information is provided by the study sponsor or research team.

Eneida R Rabelo da Silva, ScD

CONTACT

[email protected]

5551998068616

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Hospital Moinhos de Vento
  • Irmandade Santa Casa de Misericórdia de Porto Alegre

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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