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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massimiliano Carassiti, Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT01763801
First received: January 3, 2013
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Vascular Access Complication
Device: P-Max
Device: P-Submax
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Further study details as provided by Campus Bio-Medico University:

Primary Outcome Measures:
  • Distance between tracheal carina and distal end of the catheter [ Time Frame: up to 10 months ] [ Designated as safety issue: Yes ]

Enrollment: 326
Study Start Date: July 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763801

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

No publications provided

Responsible Party: Massimiliano Carassiti, Professor, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT01763801     History of Changes
Other Study ID Numbers: CaraPros
Study First Received: January 3, 2013
Last Updated: January 7, 2013
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on April 17, 2014