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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01763801
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : January 9, 2013
Information provided by (Responsible Party):
Massimiliano Carassiti, Campus Bio-Medico University

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.

Condition or disease Intervention/treatment Phase
Vascular Access Complication Device: P-Max Device: P-Submax Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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.
Study Start Date : July 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Active Comparator: P-Max group
Includes cases in which the catheter tip was considered correctly positioned when the Maximal P wave was obtained
Device: P-Max
tip placement in correspondence to the P-Max on the ECG
Active Comparator: P-Submax group
Includes cases in which the catheter tip was considered correctly positioned when the Submaximal P wave was obtained
Device: P-Submax
tip placement in correspondence to the P-Submax on the ECG

Primary Outcome Measures :
  1. Distance between tracheal carina and distal end of the catheter [ Time Frame: up to 10 months ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01763801

University Hospital Campus BioMedico
Rome, Italy
Sponsors and Collaborators
Campus Bio-Medico University
Principal Investigator: Massimiliano Carassiti, Professor Campus Bio-Medico University
Principal Investigator: Paola Proscia, Doctor Campus Bio-Medico University

Responsible Party: Massimiliano Carassiti, Professor, Campus Bio-Medico University Identifier: NCT01763801     History of Changes
Other Study ID Numbers: CaraPros
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: January 9, 2013
Last Verified: January 2013

Keywords provided by Massimiliano Carassiti, Campus Bio-Medico University:
chemo port
intravenous electrocardiographic guidance
P maximal wave
P submaximal wave
catheter tip