Comparing two techniques for inserting central catheters in adults
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
This study is testing if a special way of putting in central catheters can help adults avoid complications like infections and blood clots better than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 1 site (Porto Alegre) |
| Trial ID | NCT06365528 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized clinical trial aims to compare the tunneling technique of peripherally inserted central catheters (PICC) with the non-tunneled technique in adult patients. The study will assess the incidence of complications such as bloodstream infections, thrombosis, and catheter dislodgement over a 30-day period. By utilizing best practices and advanced techniques, the trial seeks to determine if tunneling can further reduce complications associated with PICC insertion. The research is motivated by recent findings that suggest tunneling may lead to longer device dwell times and lower complication rates.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older who require PICC insertion during their hospital stay.
Not a fit: Patients with chronic kidney disease or those in critical condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and reduced complications for patients requiring central venous access.
How similar studies have performed: Previous studies have shown promising results for the tunneling technique, indicating potential benefits over conventional methods.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Porto Alegre
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Brazil (Recruiting)
Study contacts
- Principal investigator: Eneida R Rabelo da Silva, ScD — Hospital de Clínicas de Porto Alegre
- Study coordinator: Eneida R Rabelo da Silva, ScD
- Email: eneidarabelo@gmail.com
- Phone: 5551998068616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.