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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763801
• Other study ID #: CaraPros
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2013
• Last updated: January 7, 2013
• Start date: July 2011
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• indication to chemo port insertion

• ability to give informed consent

Exclusion Criteria:

• younger than 18

• inability to give consent

• atrial fibrillation or flutter

• pace-maker or implantable cardioverter-defibrillator

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

Intervention

Device:
• P-Max
tip placement in correspondence to the P-Max on the ECG
• P-Submax
tip placement in correspondence to the P-Submax on the ECG

Locations

Country	Name	City	State
Italy	University Hospital Campus BioMedico	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance between tracheal carina and distal end of the catheter		up to 10 months	Yes