Vascular Access Complication
Conditions
Keywords
chemo port, intravenous electrocardiographic guidance, P maximal wave, P submaximal wave, catheter tip
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.
Interventions
DEVICEP-Max
tip placement in correspondence to the P-Max on the ECG
DEVICEP-Submax
tip placement in correspondence to the P-Submax on the ECG
Sponsors
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance between tracheal carina and distal end of the catheter | up to 10 months |
Countries
Italy
Outcome results
None listed