Rational for the Use of Velocity-Pressure Loop in the Operating Room

NCT03853226 | Completed

• 1 other identifier: SRLF 11-356
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

In surgical patients considered with "high cardiovascular risk", by their field or by the nature of their intervention, it is recommended to use hemodynamic monitoring including a continuous measurement device of arterial pressure and cardiac output (CO). However, targeting mean arterial pressure (MAP) with boluses of selective peripheral vasopressors (without positive inotropic or chronotropic effects) could have deleterious effects on CO. Thus, it seems important to use a combined analysis of MAP and CO to estimate the afterload-related cardiac performance (ACP) The investigators recently proposed a cardiac afterload monitoring, in the descending thoracic aorta, based on a combined analysis of flow velocity signal recorded by trans-oesophageal Doppler and aortic pressure, the Velocity-Pressure Loop (VP Loop). VP Loop, and its derived indicators, especially Global AfterLoad Angle (GALA), could be useful during hemodynamic management for continuous cardiac afterload monitoring. However, in cardiology unit, cardiac afterload is usually measured at the ascending aorta behind the aortic valves. The main objective of this study is to compare VP Loop parameters build in the ascending and descending thoracic aorta according to patient cardiovascular risk factors.

Conditions

Radiography; Interventional

Keywords

After-load cardiac performance; high cardiovascular risk; surgical patient

Outcome Measures

Primary Outcomes (3)

• Measure of aortic pressure in the ascending aorta and 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 surgical intervention or interventional neuroradiology procedure (maximum 1 day)]

• Aortic velocity in the ascending aorta in cm/s (VAasc.)

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

  Duration of the surgical intervention or 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 surgical intervention or interventional neuroradiology procedure (maximum 1 day)]

Interventions

All monitoring PROCEDURE

For all patients, data from trans-esophageal Doppler, trans-thoracic echocardiography (TTE) and hemodynamic data are collected at the end of the procedure. During catheter withdrawal, pressure waveforms are recorded at two predefined aortic locations: in the ascending aorta and in the descending thoracic aorta just in front of the esophageal Doppler probe.

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 with scheduled 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 an elective interventional neuroradiology procedure under general anesthesia requiring a continuous monitoring of mean arterial pressure and cardiac output.
• oral agreement obtained from each patient before anesthesia

You may not qualify if:

• age \<18 years
• an emergency procedure

Sponsors & Collaborators

• Joaquim MATEO: lead
• INSERM UMR-942, Paris, France: collaborator
• M3DISIM: collaborator

Study Officials

• Joaquim MATEO, MD

  HLariboisière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 25, 2019
• Study Start: January 5, 2014
• Primary Completion: January 25, 2016
• Study Completion: March 25, 2016
• Last Updated: February 27, 2019

Record last verified: 2019-02