NCT01763801

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Campus Bio-Medico University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Vascular Access Complication

Interventions

Type	Name	Description
DEVICE	P-Max	tip placement in correspondence to the P-Max on the ECG
DEVICE	P-Submax	tip placement in correspondence to the P-Submax on the ECG

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2013-01-09
• Last updated: 2013-01-09

Locations

1 site across 1 country: Italy