Elevated Left Atrial PressurePOGETONCT04096807
Pulmonary Vein Diameter and Collapsibility Measured by TEE to Predict Elevated Left Atrial Pressure in Cardiac Surgery
An observational study of Elevated Left Atrial Pressure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Left atrial pressure (LAP) is a crucial hemodynamic parameter during cardiac surgery. Elevated LAP leads to pulmonary edema and other cardiopulmonary complications. The pulmonary capillary wedge pressure (PCWP) measured by a pulmonary arterial catheter (PAC) is the gold-standard method to estimate LAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Left Atrial Pressure
- What is being tested?
- Standard TEE exam including measurement of left upper pulmonary vein diameter and collapsibility, compared with PCWP measured continuously by a pulmonary arterial catheter
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2019to 20 Sep 2021
- Phase
- Observational
- 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
Study population: Patient admitted to the Montpellier University Hospital for cardiac surgery requiring perioperative TEE and pulmonary arterial catheter monitoring.
Who may be able to join
- Patients aged of 18 years or more,
- Scheduled for an elective cardiac surgery at the Montpellier University Hospital,
- Requiring a pulmonary arterial catheter monitoring due to the complexity of cardiac surgery or severe cardiopulmonary comorbidities.
Who cannot join
- Failure of the pulmonary artery catheterization,
- Failure of PCWP measurement,
- Failure of TEE measure of the left upper pulmonary vein diameter and collapsibility,
- Refusal to participate expressed secondarily.
- Non-inclusion criteria :
- Cardiac transplantation,
Show all 11Show fewer
- Left ventricule assist device,
- Pulmonary vein stenosis,
- Contraindications to TEE or PAC,
- Refusal to participate,
- Patient under juridical protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative and Non-invasive Estimation of Mean Left Atrial Pressure From Transesophageal Echocardiography Measures of Pulmonary Vein Diameter and Collapsibility in Cardiac Surgery: a Prospective Study
Left atrial pressure (LAP) is a crucial hemodynamic parameter during cardiac surgery. Elevated LAP leads to pulmonary edema and other cardiopulmonary complications. The pulmonary capillary wedge pressure (PCWP) measured by a pulmonary arterial catheter (PAC) is the gold-standard method to estimate LAP. However, the placement of a PAC is an invasive procedure associated with adverse events. Transesophagial echocardiophy (TEE) is a non-invasive method to estimate LAP during cardiac surgery. Pulsed Doppler mitral flow, pulmonary vein flow, tricuspid regurgitation peak flow and left atrial volume are validated parameters to estimate LAP. Nevertheless, these parameters are not always valid in cardiac surgery, mainly because of mitral valve pathology or prothesis.
As the diameter and collapsibility of inferior vena cava is the recommended method for non-invasive right atrial pressure assessment in patients under mechanical ventilation, the investigators made the hypothesis that diameter and collapsibility of the pulmonary veins could be an additional method to estimate LAP during cardiac surgery. This has never been investigated in cardiology or cardiac surgery.
In this prospective study, pulmonary vein diameter and collapsibility will be correlated to invasive PCWP to assess LAP perioperatively in 30 patients undergoing cardiac surgery
Read the detailed description
The evaluation of left ventricle filling pressures (LVFP) perioperatively in cardiac surgery could be challenging. This is particularly relevant after separation from cardiopulmonary bypass because the hemodynamic state is dynamic, with changes in heart rate, loading conditions, and deterioration in diastolic function being common. Elevated LVFP leads to pulmonary edema, arrhythmia, pulmonary hypertension and RV failure.
To estimate the LVFP, the gold standard method is the pulmonary capillary wedge pressure (PCWP) measured by a pulmonary arterial catheter (PAC). However, placement of a PAC is an invasive procedure associated with adverse events.
Recommandations released by the American Society of Echocardiography for the evaluation of left ventricular diastolic function pointed out some difficulties concerning the evaluation of elevated LAP perioperativly in cardiac surgery. The commonly used parameters, such as the mitral pulsed Doppler flow, could be faulted by mitral valve regurgitation, atrial fibrillation, or fast changes in loading conditions. In cardiac surgery, additional diagnostic methods are needed to diagnose elevated LVFP.
In the right heart, measurements of the inferior vena cava diameter and collapsibility index are recommended for the evaluation of the right atrial pressure. Since it has been previously described that alterations of the pulmonary vein Doppler flow are correlated with elevated LAP, pulmonary vein diameter dilatation or lack of collapsibility have never been investigated as a marker of elevated LAP, neither in cardiology nor in cardiac surgery.
In this study, the investigators made the hypothesis that pulmonary vein diameter increase when LAP increase (in the absence of confounding factors, such as pulmonary vein stenosis or mitral regurgitation directed toward the pulmonary vein). In the same way,the investigators hypothized that cyclic variations of pulmonary vein diameter under mechanical ventilation decrease when the LAP increase. The ventilation parameters will be standardized.
The investigators will conduct a prospective study in the Department of cardiothoracic anesthesiology and critical care medicine, at the Montpellier University Hospital. Patients scheduled for an elective cardiac surgery and requiring pulmonary arterial catheter monitoring will be enrolled. The TEE standardized protocol will be performed three times, before and after cardiopulmonary bypass, and one-hour postoperatively in ICU. The mean PCWP, the standard method for measuring the LAP, will be recorded simultaneously by the pulmonary arterial catheter. For patients with atrial fibrillation, measurements will be averaged from 10 consecutive cycles.
The main objective is to correlate left upper pulmonary vein diameter and collapsibility with invasive PCWP. We have chosen to analyze the LUPV as the main marker because the LUPV is the easiest to measure among the four pulmonary veins in our clinical practice. Secondary objectives are to explore the correlation between the recommanded LAP echocardiographic parameters and the PCWP ; and to compare the area under curve (AUC) of all echocardiographic parameters to define which parameter has the best predictive value to diagnose elevated LAP. An elevated LAP is defined by a PCWP greater than 18 mmHg.
The study protocol has been approved by the Institutional Rview Board under the number 2019_IRB-MTP_05-21. The IRB waived the need for the investigator to obtain signed consent forms. We have planned to include 30 patients in this study
- Conditions
- Elevated Left Atrial Pressure
- Being tested
- Standard TEE exam including measurement of left upper pulmonary vein diameter and collapsibility, compared with PCWP measured continuously by a pulmonary arterial catheter
- Keywords
- Pulmonary wedge pressure, Atrial pressure, Left ventricle, Left ventricular function, Left atrial function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TEE exam including measurement of left upper pulmonary vein diameter and collapsibility, compared with PCWP measured continuously by a pulmonary arterial catheterOther
TEE takes part of the standard perioperative hemodynamic monitoring in cardiac surgery. Patients enrolled in the study are also monitored by a pulmonary arterial catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
left upper pulmonary vein diameter (in millimeters) measured by transesophageal echocardiography, compared to the contemporary measure of left atrial pressure by pulmonary arterial catheter.
The left upper pulmonary vein (LUPV), which enters the left atrium (LA) just lateral to the LA appendix (LAA) from an anterior to posterior trajectory, can be examined in the mid-esophageal (ME) view at 40 - 60° by slightly withdrawing and turning the probe to the left to expose the superior and lateral aspect of the LA (where the LAA is seen). The LUPV is superior (in the display) to the LAA and separated by the Coumadin ridge.
Maximal and minimal LUPV diameters will be measured (using a 10 cycle video-loop) and the collapsibility index will be calculated as the ratio : (maximum diameter ¬¬- minimum diameter) / (maximum diameter).
These echocardiographic views are part of the standard TEE exam and performed with Philips® Epiq™ 7 ultrasound machines.
Measured: Pre-cardiopulmonary bypass (15 min before bypass)
left upper pulmonary vein diameter (in millimeters) measured by transesophageal echocardiography, compared to the contemporary measure of left atrial pressure by pulmonary arterial catheter.
The left upper pulmonary vein (LUPV), which enters the left atrium (LA) just lateral to the LA appendix (LAA) from an anterior to posterior trajectory, can be examined in the mid-esophageal (ME) view at 40 - 60° by slightly withdrawing and turning the probe to the left to expose the superior and lateral aspect of the LA (where the LAA is seen). The LUPV is superior (in the display) to the LAA and separated by the Coumadin ridge.
Maximal and minimal LUPV diameters will be measured (using a 10 cycle video-loop) and the collapsibility index will be calculated as the ratio : (maximum diameter ¬¬- minimum diameter) / (maximum diameter).
These echocardiographic views are part of the standard TEE exam and performed with Philips® Epiq™ 7 ultrasound machines.
Measured: Post-cardiopulmonary bypass (15 min after bypass)
left upper pulmonary vein diameter (in millimeters) measured by transesophageal echocardiography, compared to the contemporary measure of left atrial pressure by pulmonary arterial catheter.
The left upper pulmonary vein (LUPV), which enters the left atrium (LA) just lateral to the LA appendix (LAA) from an anterior to posterior trajectory, can be examined in the mid-esophageal (ME) view at 40 - 60° by slightly withdrawing and turning the probe to the left to expose the superior and lateral aspect of the LA (where the LAA is seen). The LUPV is superior (in the display) to the LAA and separated by the Coumadin ridge.
Maximal and minimal LUPV diameters will be measured (using a 10 cycle video-loop) and the collapsibility index will be calculated as the ratio : (maximum diameter ¬¬- minimum diameter) / (maximum diameter).
These echocardiographic views are part of the standard TEE exam and performed with Philips® Epiq™ 7 ultrasound machines.
Measured: One hour postoperatively in ICU
Secondary outcomes (9)
Measurement of the other pulmonary vein diameters
Measurement of the other pulmonary vein diameters (in millimeter) : left lower, right upper, right lower pulmonary veins.
Measured: Pre-cardiopulmonary bypass (15 min before bypass)
Measurement of the other pulmonary vein diameters
Measurement of the other pulmonary vein diameters (in millimeter) : left lower, right upper, right lower pulmonary veins.
Measured: Post-cardiopulmonary bypass (15 min after bypass)
Measurement of the other pulmonary vein diameters
Measurement of the other pulmonary vein diameters (in millimeter) : left lower, right upper, right lower pulmonary veins.
Measured: One hour postoperatively in ICU
Calculation of collapsibility indexes of left upper and right upper pulmonary veins
Calculation of collapsibility indexes of left upper and right upper pulmonary veins. NB: collapsibility index = (maximal diameter - minimal diameter) / (maximal diameter)
- Mitral annulus velocities by Tissue Doppler Imaging. Calculation of collapsibility indexes of left upper and right upper pulmonary veins. NB: collapsibility index = (maximal diameter - minimal diameter) / (maximal diameter)
Measured: Pre-cardiopulmonary bypass (15 min before bypass)
Calculation of collapsibility indexes of left upper and right upper pulmonary veins
Calculation of collapsibility indexes of left upper and right upper pulmonary veins. NB: collapsibility index = (maximal diameter - minimal diameter) / (maximal diameter)
- Mitral annulus velocities by Tissue Doppler Imaging. Calculation of collapsibility indexes of left upper and right upper pulmonary veins. NB: collapsibility index = (maximal diameter - minimal diameter) / (maximal diameter)
Measured: Post-cardiopulmonary bypass (15 min after bypass)
Calculation of collapsibility indexes of left upper and right upper pulmonary veins
Calculation of collapsibility indexes of left upper and right upper pulmonary veins. NB: collapsibility index = (maximal diameter - minimal diameter) / (maximal diameter)
- Mitral annulus velocities by Tissue Doppler Imaging. Calculation of collapsibility indexes of left upper and right upper pulmonary veins. NB: collapsibility index = (maximal diameter - minimal diameter) / (maximal diameter)
Measured: One hour postoperatively in ICU
Measurement of the other echocardiographic parameters estimating the LAP or the left ventricle diastolic function
Measurement of the other echocardiographic parameters estimating the LAP or the left ventricle diastolic function : LUPV Doppler flow (S wave, D wave, Ar wave, expressed in m/s), Pulsed Doppler mitral flow (E wave, Am wave, expressed in m/s, E/A ratio, difference Ar -Am), Mitral annulus velocities by Tissue Doppler Imaging (e' velocity, a' velocity, exressed in cm/s), Left atrial area (cm2) and left atrial volume (ml), Left atrial 2D-strain (expressed in negative percentage), Tricuspid regurgitation maximal velocity (in m/s), isovolumic relaxation time (in ms)
Measured: Pre-cardiopulmonary bypass (15 min before bypass)
Measurement of the other echocardiographic parameters estimating the LAP or the left ventricle diastolic function
Measurement of the other echocardiographic parameters estimating the LAP or the left ventricle diastolic function : LUPV Doppler flow (S wave, D wave, Ar wave, expressed in m/s), Pulsed Doppler mitral flow (E wave, Am wave, expressed in m/s, E/A ratio, difference Ar -Am), Mitral annulus velocities by Tissue Doppler Imaging (e' velocity, a' velocity, exressed in cm/s), Left atrial area (cm2) and left atrial volume (ml), Left atrial 2D-strain (expressed in negative percentage), Tricuspid regurgitation maximal velocity (in m/s), isovolumic relaxation time (in ms)
Measured: Post-cardiopulmonary bypass (15 min after bypass)
Measurement of the other echocardiographic parameters estimating the LAP or the left ventricle diastolic function
Measurement of the other echocardiographic parameters estimating the LAP or the left ventricle diastolic function : LUPV Doppler flow (S wave, D wave, Ar wave, expressed in m/s), Pulsed Doppler mitral flow (E wave, Am wave, expressed in m/s, E/A ratio, difference Ar -Am), Mitral annulus velocities by Tissue Doppler Imaging (e' velocity, a' velocity, exressed in cm/s), Left atrial area (cm2) and left atrial volume (ml), Left atrial 2D-strain (expressed in negative percentage), Tricuspid regurgitation maximal velocity (in m/s), isovolumic relaxation time (in ms)
Measured: One hour postoperatively in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start8 Aug 2019
- Primary completion1 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Left Atrial PressureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Sentenac, M.D, Principal investigator, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096807
- Sponsor's protocol ID
- RECHMPL19_0258
- Acronym
- POGETO
- Status last verified
- Oct 2021
- First submitted
- 8 Aug 2019
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative and Non-invasive Estimation of Mean Left Atrial Pressure From Transesophageal Echocardiography Measures of Pulmonary Vein Diameter and Collapsibility in Cardiac Surgery: a Prospective Study
- ClinicalTrials.gov ID
- NCT04096807
- Acronym / sponsor ID
- POGETO / RECHMPL19_0258
- Conditions
- Elevated Left Atrial Pressure
- Keywords
- Pulmonary wedge pressure, Atrial pressure, Left ventricle, Left ventricular function, Left atrial function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 20 Sep 2019 (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.
Left atrial pressure (LAP) is a crucial hemodynamic parameter during cardiac surgery. Elevated LAP leads to pulmonary edema and other cardiopulmonary complications. The pulmonary capillary wedge pressure (PCWP) measured by a pulmonary arterial catheter (PAC) is the gold-standard method to estimate LAP. However, the placement of a PAC is an invasive procedure associated with adverse events. Transesophagial echocardiophy (TEE) is a non-invasive method to estimate LAP during cardiac surgery. Pulsed Doppler mitral flow, pulmonary vein flow, tricuspid regurgitation peak flow and left atrial volume are validated parameters to estimate LAP. Nevertheless, these parameters are not always valid in cardiac surgery, mainly because of mitral valve pathology or prothesis.
As the diameter and collapsibility of inferior vena cava is the recommended method for non-invasive right atrial pressure assessment in patients under mechanical ventilation, the investigators made the hypothesis that diameter and collapsibility of the pulmonary veins could be an additional method to estimate LAP during cardiac surgery. This has never been investigated in cardiology or cardiac surgery.
In this prospective study, pulmonary vein diameter and collapsibility will be correlated to invasive PCWP to assess LAP perioperatively in 30 patients undergoing cardiac surgery
Detailed description
The evaluation of left ventricle filling pressures (LVFP) perioperatively in cardiac surgery could be challenging. This is particularly relevant after separation from cardiopulmonary bypass because the hemodynamic state is dynamic, with changes in heart rate, loading conditions, and deterioration in diastolic function being common. Elevated LVFP leads to pulmonary edema, arrhythmia, pulmonary hypertension and RV failure.
To estimate the LVFP, the gold standard method is the pulmonary capillary wedge pressure (PCWP) measured by a pulmonary arterial catheter (PAC). However, placement of a PAC is an invasive procedure associated with adverse events.
Recommandations released by the American Society of Echocardiography for the evaluation of left ventricular diastolic function pointed out some difficulties concerning the evaluation of elevated LAP perioperativly in cardiac surgery. The commonly used parameters, such as the mitral pulsed Doppler flow, could be faulted by mitral valve regurgitation, atrial fibrillation, or fast changes in loading conditions. In cardiac surgery, additional diagnostic methods are needed to diagnose elevated LVFP.
In the right heart, measurements of the inferior vena cava diameter and collapsibility index are recommended for the evaluation of the right atrial pressure. Since it has been previously described that alterations of the pulmonary vein Doppler flow are correlated with elevated LAP, pulmonary vein diameter dilatation or lack of collapsibility have never been investigated as a marker of elevated LAP, neither in cardiology nor in cardiac surgery.
In this study, the investigators made the hypothesis that pulmonary vein diameter increase when LAP increase (in the absence of confounding factors, such as pulmonary vein stenosis or mitral regurgitation directed toward the pulmonary vein). In the same way,the investigators hypothized that cyclic variations of pulmonary vein diameter under mechanical ventilation decrease when the LAP increase. The ventilation parameters will be standardized.
The investigators will conduct a prospective study in the Department of cardiothoracic anesthesiology and critical care medicine, at the Montpellier University Hospital. Patients scheduled for an elective cardiac surgery and requiring pulmonary arterial catheter monitoring will be enrolled. The TEE standardized protocol will be performed three times, before and after cardiopulmonary bypass, and one-hour postoperatively in ICU. The mean PCWP, the standard method for measuring the LAP, will be recorded simultaneously by the pulmonary arterial catheter. For patients with atrial fibrillation, measurements will be averaged from 10 consecutive cycles.
The main objective is to correlate left upper pulmonary vein diameter and collapsibility with invasive PCWP. We have chosen to analyze the LUPV as the main marker because the LUPV is the easiest to measure among the four pulmonary veins in our clinical practice. Secondary objectives are to explore the correlation between the recommanded LAP echocardiographic parameters and the PCWP ; and to compare the area under curve (AUC) of all echocardiographic parameters to define which parameter has the best predictive value to diagnose elevated LAP. An elevated LAP is defined by a PCWP greater than 18 mmHg.
The study protocol has been approved by the Institutional Rview Board under the number 2019_IRB-MTP_05-21. The IRB waived the need for the investigator to obtain signed consent forms. We have planned to include 30 patients in this study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to the Montpellier University Hospital for cardiac surgery requiring perioperative TEE and pulmonary arterial catheter monitoring.
Key inclusion criteria (3 listed)
- Patients aged of 18 years or more,
- Scheduled for an elective cardiac surgery at the Montpellier University Hospital,
- Requiring a pulmonary arterial catheter monitoring due to the complexity of cardiac surgery or severe cardiopulmonary comorbidities.
Key exclusion criteria (11 listed)
- Failure of the pulmonary artery catheterization,
- Failure of PCWP measurement,
- Failure of TEE measure of the left upper pulmonary vein diameter and collapsibility,
- Refusal to participate expressed secondarily.
- Cardiac transplantation,
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 |
|---|---|---|
| Standard TEE exam including measurement of left upper pulmonary vein diameter and collapsibility, compared with PCWP measured continuously by a pulmonary arterial catheterTEE takes part of the standard perioperative hemodynamic monitoring in cardiac surgery. Patients enrolled in the study are also monitored by a pulmonary arterial catheter | Other | – |
Primary outcome
left upper pulmonary vein diameter (in millimeters) measured by transesophageal echocardiography, compared to the contemporary measure of left atrial pressure by pulmonary arterial catheter.
Time frame: Pre-cardiopulmonary bypass (15 min before bypass)
The left upper pulmonary vein (LUPV), which enters the left atrium (LA) just lateral to the LA appendix (LAA) from an anterior to posterior trajectory, can be examined in the mid-esophageal (ME) view at 40 - 60° by slightly withdrawing and turning the probe to the left to expose the superior and lateral aspect of the LA (where the LAA is seen). The LUPV is superior (in the display) to the LAA and separated by the Coumadin ridge. Maximal and minimal LUPV diameters will be measured (using a 10 cycle video-loop) and the collapsibility index will be calculated as the ratio : (maximum diameter ¬¬- minimum diameter) / (maximum diameter). These echocardiographic views are part of the standard TEE exam and performed with Philips® Epiq™ 7 ultrasound machines.
left upper pulmonary vein diameter (in millimeters) measured by transesophageal echocardiography, compared to the contemporary measure of left atrial pressure by pulmonary arterial catheter.
Time frame: Post-cardiopulmonary bypass (15 min after bypass)
The left upper pulmonary vein (LUPV), which enters the left atrium (LA) just lateral to the LA appendix (LAA) from an anterior to posterior trajectory, can be examined in the mid-esophageal (ME) view at 40 - 60° by slightly withdrawing and turning the probe to the left to expose the superior and lateral aspect of the LA (where the LAA is seen). The LUPV is superior (in the display) to the LAA and separated by the Coumadin ridge. Maximal and minimal LUPV diameters will be measured (using a 10 cycle video-loop) and the collapsibility index will be calculated as the ratio : (maximum diameter ¬¬- minimum diameter) / (maximum diameter). These echocardiographic views are part of the standard TEE exam and performed with Philips® Epiq™ 7 ultrasound machines.
left upper pulmonary vein diameter (in millimeters) measured by transesophageal echocardiography, compared to the contemporary measure of left atrial pressure by pulmonary arterial catheter.
Time frame: One hour postoperatively in ICU
The left upper pulmonary vein (LUPV), which enters the left atrium (LA) just lateral to the LA appendix (LAA) from an anterior to posterior trajectory, can be examined in the mid-esophageal (ME) view at 40 - 60° by slightly withdrawing and turning the probe to the left to expose the superior and lateral aspect of the LA (where the LAA is seen). The LUPV is superior (in the display) to the LAA and separated by the Coumadin ridge. Maximal and minimal LUPV diameters will be measured (using a 10 cycle video-loop) and the collapsibility index will be calculated as the ratio : (maximum diameter ¬¬- minimum diameter) / (maximum diameter). These echocardiographic views are part of the standard TEE exam and performed with Philips® Epiq™ 7 ultrasound machines.
9 secondary outcomes
Measurement of the other pulmonary vein diameters
Time frame: Pre-cardiopulmonary bypass (15 min before bypass)
Measurement of the other pulmonary vein diameters
Time frame: Post-cardiopulmonary bypass (15 min after bypass)
Measurement of the other pulmonary vein diameters
Time frame: One hour postoperatively in ICU
Calculation of collapsibility indexes of left upper and right upper pulmonary veins
Time frame: Pre-cardiopulmonary bypass (15 min before bypass)
Calculation of collapsibility indexes of left upper and right upper pulmonary veins
Time frame: Post-cardiopulmonary bypass (15 min after bypass)
Calculation of collapsibility indexes of left upper and right upper pulmonary veins
Time frame: One hour postoperatively in ICU
Measurement of the other echocardiographic parameters estimating the LAP or the left ventricle diastolic function
Time frame: Pre-cardiopulmonary bypass (15 min before bypass)
Measurement of the other echocardiographic parameters estimating the LAP or the left ventricle diastolic function
Time frame: Post-cardiopulmonary bypass (15 min after bypass)
Measurement of the other echocardiographic parameters estimating the LAP or the left ventricle diastolic function
Time frame: One hour postoperatively in ICU
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 25 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Pierre Sentenac, M.D principal investigator
UH MONTPELLIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elevated Left Atrial Pressure, run by University Hospital, Montpellier 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 3 inclusion and 11 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 25 Oct 2021. 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 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?
left upper pulmonary vein diameter (in millimeters) measured by transesophageal echocardiography, compared to the contemporary measure of left atrial pressure by pulmonary arterial catheter. (time frame: Pre-cardiopulmonary bypass (15 min before bypass)). The study lists 3 primary outcomes in all. 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 25 Oct 2021.