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OpenTrials
Completed

NCT Number: NCT01763801

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

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.

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Key information

Conditions

Vascular Access Complication

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Campus BioMedico

Rome, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

P-Max

Device

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

P-Submax

Device

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

Primary outcomes

  1. Distance between tracheal carina and distal end of the catheter

    Time frame: up to 10 months

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 9, 2013
Registry last updated
Jan 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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