Optimization of EKG Method for Long Term Central Venous Catheter Tip Placement

Vascular Access Complication Clinical Trial

Official title: P-max or P-submax? This is the Question! A Prospective Randomized Search of the Most Reliable ECG Landmark for a Long Term Central Venous Catheter.

Status Completed

Clinical Trial Summary

Intravenous electrocardiographic guidance (IVECG) is a safe, reliable and accurate technique to correctly position the catheter tip. The investigators sought to evaluate the superiority of the P-maximal (P-max) wave compared to the P-submaximal (P-submax) wave in obtaining a more correct, safer and longer lasting device placement, with a lower incidence of complications and secondary misplacement.

Clinical Trial Description

This prospective randomized trial was designed to observe the placement of long term iv catheters obtained with the IVECG method. Patients were randomised into 2 groups: in group A the catheter tip was placed in correspondence to the P-max, in group B in correspondence to the P-submax. We followed up the tip position by measuring the variation of its distances from the tracheal carina on multiplanar reconstructions of volumetric CT scans taken within a month (T0) and a year (T1) from the port implant. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vascular Access Complication

• NCT number: NCT01763801
• Study type: Interventional
• Source: Campus Bio-Medico University
• Status: Completed
• Phase: Phase 4
• Start date: July 2011
• Completion date: March 2012