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

NCT03921164 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2024-06-24

No results posted yet for this study

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.

Conditions

  • Radiography
  • Interventional

Interventions

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).

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.

Sponsors & Collaborators

  • INSERM UMR-942, Paris, France

    collaborator OTHER
  • M3DISIM

    collaborator OTHER
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Joaquim MATEO, MD · Assistance Publique - Hôpitaux de Paris

  • Fabrice VALLEE, MD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2021-10-21
Completion
2021-10-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03921164 on ClinicalTrials.gov