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Non Invasive Use of Pressure-Volume Loop in the Operating Room (LOOPING)

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ClinicalTrials.gov Identifier: NCT03921164
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
INSERM UMR-942, Paris, France
M3DISIM
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
In patients under general anesthesia, the prevention of intraoperative hypotension to maintain blood pressure (BP) close to the initial blood pressure, i.e. before anesthesia, is essential to reduce the risk of death and improve surgical outcomes. Vasoactive agents are commonly used to correct this hypotension (Phenylephrine Ephedrine Noradrenaline). These three vasoconstrictors have specific effects on the afterload of the heart and can impair its function. The analysis of the left ventricular pressure-volume curve (PV Loop) allows continuous information on the post-charge state of the left ventricle and the changes induced by the vasoconstrictors to be observed. However, the investigators currently have no way of monitoring these effects. In clinical practice if these loops are obtained non-invasively they can be used in the evaluation of cardiac function of at-risk patients in perioperative and also in intensive care to allow therapeutic adaptation.

Condition or disease Intervention/treatment
Radiography Interventional Procedure: Trans-oesophageal Doppler Procedure: Trans-thoracic echocardiography Procedure: Applanation tonometry

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Non Invasive Pressure -Volume Loop (PVLOOP) With 3D Echocardiography and Arterial Tonometry
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Group/Cohort Intervention/treatment
Patients scheduled for a neuroradiology procedure
Interventional neuroradiology procedure under general anesthesia requiring a continuous monitoring of mean arterial pressure and cardiac output, including electrocardiogram, pulsated oxygen saturation, endtidal CO2, respiratory rate, tidal volume and monitoring of neuromuscular function. In addition, for all patients, data from trans-oesophageal Doppler, trans-thoracic echocardiography (TTE) and hemodynamic data are collected at the end of the procedure. During catheter withdrawal, pressure waveforms are recorded in the descending thoracic aorta just in front of the esophageal Doppler probe.
Procedure: Trans-oesophageal Doppler

As required by the standard of care of the interventional neuroradiology procedure, the neuroradiologist also cannulates the femoral artery. At the end of the procedure, during catheter withdrawal, pressure waveforms are recorded in the descending thoracic aorta just in front of the esophageal Doppler probe.

Descending aortic velocity is measured with a transesophageal Doppler CardioQ-ODM+ (Deltex Medical, Chichester, UK) in order to construct the VP Loop in descending thoracic aorta.


Procedure: Trans-thoracic echocardiography
Estimation of ventricular diastolic pressure by measuring mitral and aortic flow gradients by echocardiography (EPIQ G7 Philips© or similar) Determination of left ventricular volumes during the cardiac cycle by echocardiography (3D EPIQ G7 Philips© or similar).
Other Name: TTE

Procedure: Applanation tonometry

Measurements using the SphygmoCor radial tonometer (AtCor Medical, Pty Ltd, Sydney, Australia), the most widely used tonometer in clinical research for non-invasive central pressure measurement and pulse wave analysis. The central blood pressure is then estimated using a validated radial-aortic transfer function.

The tonometer requires prior calibration by mean (MAP) and diastolic (PAD) blood pressure measured with the conventional brachial cuff as validated in the literature.





Primary Outcome Measures :
  1. Aortic pressure in the descending thoracic aorta in mmHg (PAo) [ Time Frame: Duration of the interventional neuroradiology procedure (maximum 1 day) ]
    For all patients, aortic pressure will be collected at the end of the procedure during catheter withdrawal

  2. Aortic velocity in the descending aorta in cm/s (VAdes.) [ Time Frame: Duration of the interventional neuroradiology procedure (maximum 1 day) ]
    For all patients, aortic descending velocity will be collected at the end of the procedure during catheter withdrawal.

  3. Central pressure by tonometry (CP in mmHg) [ Time Frame: Duration of the interventional neuroradiology procedure (maximum 1 day) ]
    For all patients, central pressure by tonometry will be collected at the end of the procedure.

  4. Ventricular diastolic pressure (VdP in mmHg) [ Time Frame: Duration of the interventional neuroradiology procedure (maximum 1 day) ]
    For all patients, ventricular diastolic pressure by 3D echocardiography will be collected at the end of the procedure.

  5. Left ventricular volume (LVV in mL) [ Time Frame: Duration of the interventional neuroradiology procedure (maximum 1 day) ]
    For all patients, left ventricular volume by 3D echocardiography will be collected at the end of the procedure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for an elective interventional neuroradiology procedure under general anesthesia requiring a continuous monitoring of mean arterial pressure and cardiac output.
Criteria

Inclusion Criteria:

  • Patients > 18 years, scheduled for an elective interventional neuroradiology procedure under general anesthesia requiring a continuous monitoring of mean arterial pressure and cardiac output.

Exclusion Criteria:

  • age <18 years
  • Patient who has not signed the consent
  • Pregnant woman
  • Patient under judicial protection
  • Patient without affiliation to a social security scheme

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921164


Contacts
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Contact: Joaquim MATEO, MD +33 1 49 95 83 74 joaquim.mateo@aphp.fr
Contact: Fabrice VALLEE, MD +33 1 49 95 83 09 fabrice.vallee@gmail.com

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
INSERM UMR-942, Paris, France
M3DISIM
Investigators
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Study Director: Joaquim MATEO, MD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Fabrice VALLEE, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03921164     History of Changes
Other Study ID Numbers: APHP180410
2018-A02737-48 ( Other Identifier: IDRCB )
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cardiac after-load
Pressure volume loop
Perioperative risk