EchocardiographyEchoPACNCT03133962
Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter
A study testing Adult patients who are candidates for a CAP or long-term central catheter placement in people with Echocardiography and Implantable Chamber, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Given the increase in the number of PAC implants or long-term catheters, and the ease of access to cardiac ultrasound in the operating theaters, the investigator thought to use ultrasound to PAC or long-term catheters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, Implantable Chamber
- What is being tested?
- Adult patients who are candidates for a CAP or long-term central catheter placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2014to 21 Apr 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients are candidates for a long-term CAP or central catheter placement.
- Benefiting from sedation or general anesthesia.
Who cannot join
- Patient aged <18 years.
- Pregnant woman.
- Lack of anesthesiologist with knowledge of ultrasound.
- Site of femoral puncture
Trial locations and contacts
1 site in 1 country.
About this study
Given the increase in the number of PAC implants or long-term catheters, and the ease of access to cardiac ultrasound in the operating theaters, the investigator thought to use ultrasound to PAC or long-term catheters.
The investigator considers cardiac echocardiography through its costal pathway to locate the correct positioning of the distal end of the catheter in a manner equivalent to the scopic locating with all the side effects of the irradiation and with Equivalent efficiency
- Conditions
- Echocardiography, Implantable Chamber
- Being tested
- Adult patients who are candidates for a CAP or long-term central catheter placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult patients who are candidates for a CAP or long-term central catheter placementOther
Evaluate the feasibility of finding the correct positioning of the distal end of the PAC or of the long-term catheter by cardiac ultrasound in comparison with the brightness scopy, reference method.
| Study group | Role | What they receive |
|---|---|---|
| Patients applying for CAP or long-term central catheter | Other | Not described Receives: Other: Adult patients who are candidates for a CAP or long-term central catheter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good positioning of the distal end of the catheter by ETT, without repositioning following the scopy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start3 Nov 2014
- Primary completion21 Apr 2017
- Study completion21 Apr 2017
Why it stopped: Decision of the investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133962
- Sponsor's protocol ID
- PI2014_843_0013
- Acronym
- EchoPAC
- Status last verified
- May 2017
- First submitted
- 25 Apr 2017
- Last updated
- 12 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter
- ClinicalTrials.gov ID
- NCT03133962
- Acronym / sponsor ID
- EchoPAC / PI2014_843_0013
- Conditions
- Echocardiography, Implantable Chamber
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision of the investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 3 Nov 2014 (actual)
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 28 Apr 2017 (actual)
- 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.
Given the increase in the number of PAC implants or long-term catheters, and the ease of access to cardiac ultrasound in the operating theaters, the investigator thought to use ultrasound to PAC or long-term catheters.
The investigator considers cardiac echocardiography through its costal pathway to locate the correct positioning of the distal end of the catheter in a manner equivalent to the scopic locating with all the side effects of the irradiation and with Equivalent efficiency
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients applying for CAP or long-term central catheter | Other | Other: Adult patients who are candidates for a CAP or long-term central catheter placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients are candidates for a long-term CAP or central catheter placement.
- Benefiting from sedation or general anesthesia.
Key exclusion criteria (4 listed)
- Patient aged <18 years.
- Pregnant woman.
- Lack of anesthesiologist with knowledge of ultrasound.
- Site of femoral puncture
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 |
|---|---|---|
| Adult patients who are candidates for a CAP or long-term central catheter placementEvaluate the feasibility of finding the correct positioning of the distal end of the PAC or of the long-term catheter by cardiac ultrasound in comparison with the brightness scopy, reference method. | Other | Patients applying for CAP or long-term central catheter |
Primary outcome
Good positioning of the distal end of the catheter by ETT, without repositioning following the scopy
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
Related trials for Echocardiography
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure
Heart Failure
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adult patients who are candidates for a CAP or long-term central catheter placement in people with Echocardiography and Implantable Chamber, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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: withdrawn, as of the sponsor's last update on 12 May 2017. 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 France. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Good positioning of the distal end of the catheter by ETT, without repositioning following the scopy (time frame: 1 day). 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 12 May 2017.