Dynamic Estimation of Cardiac Output in the Operating Room

NCT04926220 | Unknown

• 2 other identifiers: APHP2103112021-A00088-33
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

During major surgery, it is recommended to monitor invasive arterial blood pressure and cardiac output (CO) during hemodynamic interventions (fluid challenge or vasopressors). Esophageal Doppler is currently considered as the reference method for monitoring cardiac output in the operating room. The PRAM method (pressure recording analytical method) with the MostCareUp monitor (Vytech, Padova, Italy) and the LTIA method (long time interval analysis) allow cardiac output estimation derived from non-calibrated arterial pressure waveform analysis. Few studies have looked at relative changes in cardiac output during hemodynamic intervention with these two methods. The aim of this study is to compare the relative changes in cardiac output during hemodynamic interventions as measured using PRAM and LTIA methods, compared to esophageal Doppler.

Conditions

Interventional Radiology; Surgery; General Anesthesia; Organ Failure; Intensive Care; Hemodynamic Instability; Blood Pressure; Cardiac Output

Keywords

Cardiac output monitoring; Pulse contour analysis; Vasopressors; Fluid challenge; Trans-esophageal doppler; Pressure recording analytical method; Long time interval analysis

Outcome Measures

Primary Outcomes (3)

• Cardiac output using the trans-esophageal Doppler technique

  Measure of cardiac output with trans-esophageal doppler (CARDIOQ-ODM; Deltex Medical, Chichester, UK) in L/min (COTOD)

  Duration of the surgery (maximum 1 day)

• Cardiac output using the MostCareUp monitor

  Measure of cardiac output with MostCareUp (Vytech, Padova, Italy) in L/min (COPRAM)

  Duration of the surgery (maximum 1 day)

• Cardiac output using the Argos monitor

  Measure of cardiac output with Argos monitor (Retia Medical, Valhalla, NY, USA) in L/min (COLTIA)

  Duration of the surgery (maximum 1 day)

Secondary Outcomes (7)

• Measure of the value of the dicrote wave with MostCareUp monitor

  Duration of the surgery (maximum 1 day)

• Measure of dP/dtmax (myocardial contractility index) with MostCareUp monitor

  Duration of the surgery (maximum 1 day)

• Measure of the cardiac efficiency (CCE) with MostCareUp monitor

  Duration of the surgery (maximum 1 day)

• Measure of arterial elastance with MostCareUp monitor

  Duration of the surgery (maximum 1 day)

• Measure of the total impedance of the system (Ztot) with MostCareUp monitor

  Duration of the surgery (maximum 1 day)

Study Arms (1)

Patients undergoing general anesthesia and benefiting from intraoperative hemodynamic optimization

Patients undergoing general anesthesia and benefiting from intraoperative hemodynamic optimization, including routine monitoring of blood pressure and measurement of cardiac output by trans-esophageal Doppler.

Device: Trans-esophageal Doppler monitoring; Device: MostCareUP Haemodynamic Monitor; Device: Argos Cardiac Output (CO) Monitor

Interventions

Trans-esophageal Doppler monitoring DEVICE

Trans-esophageal Doppler monitoring (CARDIOQ-ODM; Deltex Medical, Chichester, UK) for monitoring of cardiac output

Patients undergoing general anesthesia and benefiting from intraoperative hemodynamic optimization

MostCareUP Haemodynamic Monitor DEVICE

MostCareUp (Vytech, Padova, Italy) waveform analysis cardiac output monitor

Patients undergoing general anesthesia and benefiting from intraoperative hemodynamic optimization

Argos Cardiac Output (CO) Monitor DEVICE

Argos monitor (Retia Medical, Valhalla, NY, USA) for cardiac output monitoring

Patients undergoing general anesthesia and benefiting from intraoperative hemodynamic optimization

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

Adult patients eligible for an interventional radiology procedure, surgery under general anesthesia, or admitted to intensive care unit for postoperative organ failure, benefiting from intraoperative and postoperative hemodynamic optimization in intensive care including routine blood pressure monitoring and measurement of cardiac output by esophageal Doppler.

You may qualify if:

• Major patients (≥ 18 years )
• Eligible for an interventional radiology procedure or surgery under general anesthesia
• Monitoring of invasive blood pressure and cardiac output by trans-esophageal Doppler.
• Patients informed and having expressed their non-opposition to participation in this research

You may not qualify if:

• Patients under 18 years old
• Atrial fibrillation
• Contraindication to trans-esophageal doppler
• Patient opposed to protocol participation
• 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

Study Sites (1)

AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care

Paris, 75010, France

RECRUITING

MeSH Terms

Interventions

Monitoring, Physiologic

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Alex HONG, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Joaquim MATEO, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Alex HONG, MD

CONTACT

+33 (0)149958309; alex.hong@aphp.fr

Joaquim MATEO, MD

CONTACT

+33 (0)149958374; joaquim.mateo@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 15, 2021
• Study Start: September 15, 2021
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2024
• Last Updated: October 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)