Vascular Access ComplicationPhase 4NCT01763801
Optimization of EKG Method for Long Term Central Venous Catheter Tip Placement
A Phase 4 study testing P-Max and P-Submax in people with Vascular Access Complication, run by Campus Bio-Medico University at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- P-Max and P-Submax
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Mar 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication to chemo port insertion
- ability to give informed consent
Who cannot join
- younger than 18
- inability to give consent
- atrial fibrillation or flutter
- pace-maker or implantable cardioverter-defibrillator
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Vascular Access Complication
- Being tested
- P-Max, P-Submax
- Keywords
- chemo port, intravenous electrocardiographic guidance, P maximal wave, P submaximal wave, catheter tip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-MaxDevice
tip placement in correspondence to the P-Max on the ECG
P-SubmaxDevice
tip placement in correspondence to the P-Submax on the ECG
| Study group | Role | What they receive |
|---|---|---|
| P-Max group | Active comparator | Includes cases in which the catheter tip was considered correctly positioned when the Maximal P wave was obtained Receives: 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 Receives: Device: P-Submax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between tracheal carina and distal end of the catheter
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano Carassiti, Campus Bio-Medico University
- Investigators
- Massimiliano Carassiti, Professor, Principal investigator, Campus Bio-Medico UniversityPaola Proscia, Doctor, Principal investigator, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763801
- Sponsor's protocol ID
- CaraPros
- Status last verified
- Jan 2013
- First submitted
- 3 Jan 2013
- Last updated
- 9 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01763801
- Acronym / sponsor ID
- CaraPros
- Conditions
- Vascular Access Complication
- Keywords
- chemo port, intravenous electrocardiographic guidance, P maximal wave, P submaximal wave, catheter tip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P-Max group | Active comparator | Device: P-MaxIncludes cases in which the catheter tip was considered correctly positioned when the Maximal P wave was obtained |
| P-Submax group | Active comparator | Device: P-SubmaxIncludes cases in which the catheter tip was considered correctly positioned when the Submaximal P wave was obtained |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- indication to chemo port insertion
- ability to give informed consent
Key exclusion criteria (4 listed)
- younger than 18
- inability to give consent
- atrial fibrillation or flutter
- pace-maker or implantable cardioverter-defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-Maxtip placement in correspondence to the P-Max on the ECG | Device | P-Max group |
| P-Submaxtip placement in correspondence to the P-Submax on the ECG | Device | P-Submax group |
Primary outcome
Distance between tracheal carina and distal end of the catheter
Time frame: up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimiliano Carassiti, Professor principal investigator
Campus Bio-Medico University
Paola Proscia, Doctor principal investigator
Campus Bio-Medico University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing P-Max and P-Submax in people with Vascular Access Complication, run by Campus Bio-Medico University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between tracheal carina and distal end of the catheter (time frame: up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2013.