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

Campus Bio-Medico University of Rome

Status and phase: Completed; Phase 4

Conditions: Vascular Access Complication

Treatments: Device: P-Max; Device: P-Submax

Study type: Interventional

Funder types: Other

Identifiers

NCT01763801

CaraPros

Details and patient eligibility

About

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.

Full 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.

Enrollment: 326 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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326 participants in 2 patient groups

P-Max group

Active Comparator group

Description:

Includes cases in which the catheter tip was considered correctly positioned when the Maximal P wave was obtained

Treatment:

Device: P-Max

P-Submax group

Active Comparator group

Description:

Includes cases in which the catheter tip was considered correctly positioned when the Submaximal P wave was obtained

Treatment:

Device: P-Submax