NCT01763801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
Last Updated

January 9, 2013

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

January 3, 2013

Last Update Submit

January 7, 2013

Conditions

Vascular Access Complication

Keywords

chemo portintravenous electrocardiographic guidanceP maximal waveP submaximal wavecatheter tip

Outcome Measures

Primary Outcomes (1)

  • Distance between tracheal carina and distal end of the catheter

    up to 10 months

Study Arms (2)

P-Max group

ACTIVE COMPARATOR

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

Device: P-Max

P-Submax group

ACTIVE COMPARATOR

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

Device: P-Submax

Interventions

P-MaxDEVICE

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

P-Max group
P-SubmaxDEVICE

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

P-Submax group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indication to chemo port insertion
  • ability to give informed consent

You may not qualify if:

  • younger than 18
  • inability to give consent
  • atrial fibrillation or flutter
  • pace-maker or implantable cardioverter-defibrillator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Campus BioMedico

Rome, Italy

Location

Study Officials

  • Massimiliano Carassiti, Professor

    Campus Bio-Medico University

    PRINCIPAL INVESTIGATOR

  • Paola Proscia, Doctor

    Campus Bio-Medico University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 9, 2013

Study Start

July 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

January 9, 2013

Record last verified: 2013-01

Locations

IT(1)