NCT05430880

Cardiac Responsiveness Assessment by CO2

Study of the Performance of VCO2 Variation as an Indicator of Fluid Responsiveness in Intensive Care Unit

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

The increase of cardiac output resulting from increased blood volume (systolic ejection volume) during intravenous fluid administration defines a state of fluid responsiveness. Fluid responsiveness in intensive care patients with circulatory failure (shock) needs to be carefully evaluated because only half of the patients are fluid responsive and excessive fluid administration is harmful. To reliably assess this state, it is currently necessary to perform either invasive cardiac output monitoring or ultrasound evaluation before and after a fluid administration (called fluid challenge). It is either an invasive procedure or a time-consuming technique (that might depend on operator experience and patient echogenicity). The investigators foresee a potential benefit for an objective quick-answering screening tool that does not require additional monitoring. Instantaneous CO2 production rate (VCO2) calculated automatically by the most recent ventilators (Hamilton C5-C6) via the analysis of exhaled gases. There is an established physiological link between cardiac output, arterial oxygen transport to cells and CO2 production by cell metabolism. The variation in End-Tidal CO2 (another parameter derived from exhaled CO2) is conventionally monitored in the operating room; it can show sudden changes in cardiac output. In intensive care, the EtCO2 variation is probably less sensitive than the variation in VCO2 to detect changes in cardiac output. The aim of this study is to show that the variation in VCO2 as shown on ventilators during a fluid challenge test has satisfactory diagnostic performance in the detection of fluid responsiveness in patients with circulatory failure in intensive care.

Conditions

• VCO2 Variation in Intensive Care as a Marker of Fluid Responsiveness
• Cardiac Index Variation Transpulmonary Thermodilution in Patients on Controlled Ventilation With Shock

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	impact of fluid challenge on the cardiac index and CO2 respiratory parameters analysis (VCO2, EtCO2)	Preliminary daily data will record: demographic, ventilatory (tidal volume, FiO2, positive expiratory pressure, compliance, respiratory rate, I/E ratio) and biological parameters (fibrinogen, CRP, leukocytes count, PaO2, PvO2, PaCO2, PvCO2, CO2gap, arterial lactate, ScvO2, platelets count) 1. st step CO2 record (between Time-6minutes and T0; T0 corresponding to fluid challenge) VCO2 and EtCO2 (End-tidal CO2) automated measurement by Hamilton module. Average VCO2 obtained before fluid challenge. CI (cardiac index): measurement by calibration of the PiCCO module with 3 cold boli. 2. nd step: Crystalloid (ringer lactate) filling 500mL in 5 minutes 3. rd step CO2 record (between T+5min and Time+11minutes): VCO2 and EtCO2: automated measurement by Hamilton module. Average VCO2 obtained after fluid challenge. CI (cardiac index): measurement by calibration of the PiCCO module with 3 cold boli

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-03-01
• Completion: 2023-09-01
• First posted: 2022-06-24
• Last updated: 2022-06-24

Locations

1 site across 1 country: France