Efetividade do Método Tomazoni no posicionamento do Cateter Central de Inserção Periférica em neonatos comparado ao Método Tradicional: ensaio clínico randômico

Abstract

Introduction: The Peripherally Inserted Central Catheter (PICC) is essential in neonatology as it enables the safe administration of intravenous solutions. Despite its various benefits, its use is not exempt from risks, such as inadequate tip positioning. To ensure central placement, different strategies may be implemented, with anatomical landmark-based measurement being the most commonly used. The traditional measurement method, currently recommended in the literature, has shown proportions of malpositioning exceeding 90%. To address this issue, the Tomazoni Method was developed as an alternative measurement approach, resulting in a 2.7-fold higher relative risk of central positioning compared to the traditional method. However, as this was a pioneering study, further research is required to validate the method and to investigate factors that may influence positioning outcomes. Objective: To evaluate the effectiveness of the Tomazoni Method for PICC measurement in achieving central tip positioning, compared with the traditional method. Methods: Randomized, pragmatic, parallel, double-blind clinical trial. The sample consisted of PICC insertion procedures in neonates, conducted between June 2024 and April 2025. Inclusion criteria were neonates requiring PICC insertion and with venous access conditions in the upper limbs. Exclusion criteria were neonates with congenital anomalies related to venous network abnormalities, structural malformations of the upper limbs, anatomical variations in cardiac position, diaphragmatic hernia, or hemodynamic instability. The sample size calculation indicated a minimum of 44 procedures. The control group underwent the traditional measurement method, whereas the experimental group underwent the Tomazoni Method. Data collection was performed using an instrument developed based on Infusion Nurses Society recommendations, containing information on patient characteristics, insertion procedures, and catheter details. Data analysis included absolute and relative frequencies, association tests, and relative risk. The primary outcome was initial catheter tip location. The study was approved by the Research Ethics Committee of the Federal University of Minas Gerais and the study site institution. It was registered on the Brazilian Clinical Trials Registry under number RBR-55zwb45. Results: The final sample of the study consisted of 62 PICC insertion procedures. Most neonates were moderate preterm (n = 28; 45.2%), male (n = 34; 54.8%), and had low birth weight (n = 44; 70.9%). The main cause of hospitalization was prematurity (n = 28; 45.2%), and the indication for PICC insertion was the need for infusion of drugs incompatible with peripheral venous access (n = 33; 53.2%). There was no statistically significant difference in the characterization variables between the groups. A statistically significant association was found between the measurement method and the initial catheter tip position (p < 0.001), as well as between the method and the need for PICC traction (p < 0.001). Neonates in the group assessed with the Tomazoni measurement method had a 4.36-fold higher likelihood of achieving central PICC positioning compared with those in the Traditional method group. The dwell time predominantly lasted up to five days (n = 39; 62.9%), with elective removal in most cases (n = 43; 69.4%). Despite some numerical differences between groups, no other statistically significant differences were observed in the analyzed variables. Conclusion: This study demonstrated a significant association between the Tomazoni Method and central PICC positioning in neonates, supporting it as a safe strategy with the potential to improve patient safety and reduce complications associated with intravenous therapy. Although neonatal and procedural characteristics did not influence tip positioning, the findings strengthen nursing scientific evidence and contribute to the advancement of care in intravenous therapy.