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

NCT ID: NCT01763801

Last Updated: 2013-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

P-Max group

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

Group Type: ACTIVE_COMPARATOR

P-Max

Intervention Type: DEVICE

tip placement in correspondence to the P-Max on the ECG

P-Submax group

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

Group Type: ACTIVE_COMPARATOR

P-Submax

Intervention Type: DEVICE

tip placement in correspondence to the P-Submax on the ECG

Interventions

P-Max

tip placement in correspondence to the P-Max on the ECG

Intervention Type: DEVICE

P-Submax

tip placement in correspondence to the P-Submax on the ECG

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Massimiliano Carassiti

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimiliano Carassiti, Professor

Role: PRINCIPAL_INVESTIGATOR

Campus Bio-Medico University

Paola Proscia, Doctor

Role: PRINCIPAL_INVESTIGATOR

Campus Bio-Medico University

Locations

University Hospital Campus BioMedico

Rome, , Italy

Countries

Italy

Other Identifiers

CaraPros

Identifier Type: -

Identifier Source: org_study_id