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

NCT03921164 | Completed

• 2 other identifiers: APHP1804102018-A02737-48
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiography; Interventional

Keywords

Cardiac after-load; Pressure volume loop; Perioperative risk

Outcome Measures

Primary Outcomes (5)

• Aortic pressure in the descending thoracic aorta in mmHg (PAo)

  For all patients, aortic pressure will be collected at the end of the procedure during catheter withdrawal

  Duration of the interventional neuroradiology procedure (maximum 1 day)

• Aortic velocity in the descending aorta in cm/s (VAdes.)

  For all patients, aortic descending velocity will be collected at the end of the procedure during catheter withdrawal.

  Duration of the interventional neuroradiology procedure (maximum 1 day)

• Central pressure by tonometry (CP in mmHg)

  For all patients, central pressure by tonometry will be collected at the end of the procedure.

  Duration of the interventional neuroradiology procedure (maximum 1 day)

• Ventricular diastolic pressure (VdP in mmHg)

  For all patients, ventricular diastolic pressure by 3D echocardiography will be collected at the end of the procedure.

  Duration of the interventional neuroradiology procedure (maximum 1 day)

• Left ventricular volume (LVV in mL)

  For all patients, left ventricular volume by 3D echocardiography will be collected at the end of the procedure.

  Duration of the interventional neuroradiology procedure (maximum 1 day)

Study Arms (1)

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; Procedure: Trans-thoracic echocardiography; Procedure: Applanation tonometry

Interventions

Trans-oesophageal Doppler PROCEDURE

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.

Patients scheduled for a neuroradiology procedure

Trans-thoracic echocardiography PROCEDURE

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).

Also known as: TTE

Patients scheduled for a neuroradiology procedure

Applanation tonometry PROCEDURE

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.

Patients scheduled for a neuroradiology procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM UMR-942, Paris, France: collaborator
• M3DISIM: collaborator

Study Sites (1)

Department of Anesthesiology and Intensive Care, Lariboisière Hospital

Paris, 75475, France

Location

Study Officials

• Joaquim MATEO, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Fabrice VALLEE, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 19, 2019
• Study Start: January 27, 2021
• Primary Completion: October 21, 2021
• Study Completion: October 22, 2021
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

FR (1)