Ventilated PatientsNCT01947257
Is There a Correlation Between the Pulmonary Artery Pressure and the Acceleration of the Flow in the Pulmonary Artery Evaluated by Transesophageal Echocardiography (TOE) ?
A study testing the measure TRVMAX, the measure of the pulmonary artery and the direct measure of the pulmonary pressures in people with Ventilated Patients, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The measure of the pulmonary artery pressure (PAP) is a very useful index in intensive care to estimate right ventricular after load. The reference technique for this measure is the right catheterism which is an invasive technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilated Patients
- What is being tested?
- the measure TRVMAX, the measure of the pulmonary artery and the direct measure of the pulmonary pressures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Jan 2015
- 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
- Patients aged over 18 years
- Admitted to intensive care
- Mechanically ventilated and sedated
- Carrying a right catheterization
- Making a ETO indicated by the medical team or doctor in charge of the patient
Who cannot join
- Patients under 18 years
- expectant mother
- Patients without health insurance
- Refusal to close
Trial locations and contacts
1 site in 1 country.
About this study
The measure of the pulmonary artery pressure (PAP) is a very useful index in intensive care to estimate right ventricular after load. The reference technique for this measure is the right catheterism which is an invasive technique. It is possible to estimate the pulmonary artery pressure by using transthoracic echocardiography (TTE) which allows, using the continuous Doppler, the measure of maximum speed of tricuspid regurgitation (TRvmax). The measure of the TRvmax can however be difficult for intensive care patients with little echogenicity or impossible for those having no tricuspid leak. The evaluation of the tricuspid regurgitation is also particularly difficult using TOE. To avoid these drawbacks, one can use the analysis of the pulmonary ejection in the pulmonary artery (PAAT) with TOE. However, the data of the literature are controversial on this method and it was not validated in mechanically ventilated intensive care patients.
The aim of this work is to compare three methods of measure of the PAP: the measure TRVMAX (by means of the tricuspid leak) by transthoracic echocardiography, the measure of the TAAP by transesophageal ultrasound and the direct measure of the pulmonary pressures by right catheterization, in ventilated patients already monitored with a catheter in the right cavities for usual indications in intensive care (ARDS, shock). We shall analyze then the correlation between the TRVmax, the TAAP and the pressures measured by the right catheterism which serves as reference technique.
- Conditions
- Ventilated Patients
- Being tested
- the measure TRVMAX, the measure of the pulmonary artery, the direct measure of the pulmonary pressures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the measure TRVMAXOther
by transthoracic echocardiography
the measure of the pulmonary arteryOther
by transesophageal ultrasound
the direct measure of the pulmonary pressuresOther
by right catheterization
| Study group | Role | What they receive |
|---|---|---|
| ventilated patients | Other | Not described Receives: Other: the measure TRVMAX; Other: the measure of the pulmonary artery; Other: the direct measure of the pulmonary pressures |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of the pulmonary artery pressure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilated PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947257
- Sponsor's protocol ID
- 2013-A00730-45
- Other IDs
- 2013-19
- Status last verified
- Aug 2014
- First submitted
- 31 Jul 2013
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Correlation Between the Pulmonary Artery Pressure and the Acceleration of the Flow in the Pulmonary Artery Evaluated by Transesophageal Echocardiography (TOE) ?
- ClinicalTrials.gov ID
- NCT01947257
- Acronym / sponsor ID
- 2013-A00730-45
- Conditions
- Ventilated Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jan 2015 (estimated)
- First posted
- 20 Sep 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.
The measure of the pulmonary artery pressure (PAP) is a very useful index in intensive care to estimate right ventricular after load. The reference technique for this measure is the right catheterism which is an invasive technique. It is possible to estimate the pulmonary artery pressure by using transthoracic echocardiography (TTE) which allows, using the continuous Doppler, the measure of maximum speed of tricuspid regurgitation (TRvmax). The measure of the TRvmax can however be difficult for intensive care patients with little echogenicity or impossible for those having no tricuspid leak. The evaluation of the tricuspid regurgitation is also particularly difficult using TOE. To avoid these drawbacks, one can use the analysis of the pulmonary ejection in the pulmonary artery (PAAT) with TOE. However, the data of the literature are controversial on this method and it was not validated in mechanically ventilated intensive care patients.
The aim of this work is to compare three methods of measure of the PAP: the measure TRVMAX (by means of the tricuspid leak) by transthoracic echocardiography, the measure of the TAAP by transesophageal ultrasound and the direct measure of the pulmonary pressures by right catheterization, in ventilated patients already monitored with a catheter in the right cavities for usual indications in intensive care (ARDS, shock). We shall analyze then the correlation between the TRVmax, the TAAP and the pressures measured by the right catheterism which serves as reference technique.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilated patients | Other | Other: the measure TRVMAX, Other: the measure of the pulmonary artery, Other: the direct measure of the pulmonary pressures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged over 18 years
- Admitted to intensive care
- Mechanically ventilated and sedated
- Carrying a right catheterization
- Making a ETO indicated by the medical team or doctor in charge of the patient
Key exclusion criteria (4 listed)
- Patients under 18 years
- expectant mother
- Patients without health insurance
- Refusal to close
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 |
|---|---|---|
| the measure TRVMAXby transthoracic echocardiography | Other | ventilated patients |
| the measure of the pulmonary arteryby transesophageal ultrasound | Other | ventilated patients |
| the direct measure of the pulmonary pressuresby right catheterization | Other | ventilated patients |
Primary outcome
measure of the pulmonary artery pressure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
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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.
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the measure TRVMAX, the measure of the pulmonary artery and the direct measure of the pulmonary pressures in people with Ventilated Patients, run by Assistance Publique Hopitaux De Marseille 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 5 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: status not confirmed, as of the sponsor's last update on 1 Sep 2014. 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?
Results are not available in the source record.
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?
measure of the pulmonary artery pressure (time frame: 12 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 1 Sep 2014.