Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
100 participants
OBSERVATIONAL
2022-09-01
2023-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validation of the Fluid Responsiveness Index in Critically Ill Patients
NCT00894309
Study of End Tidal Carbon Dioxide (EtCO2) Variation After an End- Expiratory Occlusion Test as a Predictive Criteria of Fluid Responsiveness in Mechanically Ventilated Patients
NCT04889807
Transcutaneous pO2, Transcutaneous pCO2 and Central Venous SO2 Variations to Define Fluid Responsiveness
NCT01941472
Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients
NCT03780660
Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates for Fluid Responsiveness
NCT06390423
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
"CRAC" patients : ICU patients ventilated and shocked
Patient hospitalized in intensive care.
Patient sedated and mechanically ventilated in Volume Assisted Controlled mode.
Patient with hypotension (MAP \<65 mmHg OR SAP \<90 mmHg) AND / OR under continuous infusion of Norepinephrine / Dobutamine / Epinephrine
Patient equipped with a cardiac output measurement system by transpulmonary thermodilution (PICCO®) with a femoral arterial module; as well as a central venous route in the superior vena cava territory.
Inclusion after agreement of the patient or his trusted person after validation of the inclusion criteria and verification of the absence of exclusion criteria.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient sedated and mechanically ventilated in Volume Assisted Controlled mode.
* Patient with hypotension (MAP \<65 mmHg OR SAP \<90 mmHg) AND / OR under continuous infusion of Norepinephrine / Dobutamine / Epinephrine
* Patient equipped with a cardiac output measurement system by transpulmonary thermodilution (PICCO®) with a femoral arterial module; as well as a central venous route in the superior or inferior vena cava territory.
Exclusion Criteria
* Patient under guardianship without the possible consent of the guardian
* Pregnant woman
* Pathologies and maneuvers strongly affecting CO2 purification: Diagnosed pulmonary embolism, Prone positioning for less than 60 minutes, Exogenous intake of sodium bicarbonate less than 60 minutes ago (with the exception of an renal replacement therapy in place for more than 60 minutes)
* Recent change in respiratory quotient: Change in enteral or parenteral nutrition solution for less than 3 hours
* Pathology affecting CO2 metabolism: Fever\> 39 ° c, Intense chills.
* Patients with unstable ventilation over the hour before inclusion.
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Edouard Herriot, Anesthésie-réanimation
Lyon, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
485
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.