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Clinical Trials in France / NCT06798818
Starting soon Not applicable

Lung-cOnservative Liquid VEntilation for the Induction of Ultra-Rapid COOLing After Cardiac Arrest

NCT06798818 · tracked via the Priya Life Science France tracker
Sponsor
ORIXHA
Phase
Not applicable
Started
2025-03
Last updated
2025-01-29

Condition(s) studied

Cardiac ArrestPost Cardiac Arrest Syndrome

Investigational drug(s) / intervention(s)

Ultra-rapid therapeutic hypothermia induction by total liquid ventilation

Ultra-rapid therapeutic hypothermia induction by total liquid ventilation: Vent2Cool System is a targeted temperature management device used to induce ultra-rapid therapeutic hypothermia by total liquid ventilation.

Study summary

Out-of-hospital cardiac arrest (OHCA) affects over 356,000 individuals annually in the United States, with fewer than 10% surviving to hospital discharge, mirroring statistics from Europe. Post-cardiac arrest syndrome (PCAS), a condition causing multi-organ dysfunction, is a leading cause of mortality despite successful resuscitation efforts. Targeted temperature management (TTM) is recommended for comatose patients post-resuscitation to mitigate PCAS, but optimal temperature targets and cooling methods remain unclear. Experimental studies suggest that therapeutic hypothermia (32-34°C), induced rapidly after resuscitation, may provide significant clinical benefits.

Total liquid ventilation (TLV) with breathable liquids has been proposed to achieve ultra-rapid therapeutic hypothermia (URTH). This approach uses the lungs as a heat exchanger to achieve ultra-rapid cooling while maintaining normal gas exchange. It enables a reduction in core body temperature to the hypothermic range (33.0 ± 0.5°C) within 45 minutes in relevant experimental models.

The OverCool study is an open-label, single-arm, multi-centric pilot trial designed to evaluate the performance and safety of Vent2Cool, a medical device intended to induce ultra-rapid therapeutic hypothermia by TLV in resuscitated cardiac arrest patients. The primary objective is to demonstrate Vent2Cool's ability to achieve a target core temperature of 33.0 ± 0.5°C within 60 minutes from start of procedure in resuscitated patients admitted to the Intensive Care Unit following intra- or extra-hospital cardiac arrest. Secondary objectives include assessing procedural safety, cooling performance, feasibility in emergency settings, clinical outcomes, and the impact on biological markers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
84 Years
Healthy volunteers
No
Inclusion Criteria: * Patient resuscitated after extra- or intra-hospital cardiac arrest, from presumed cardiac or asphyxial origin, regardless of the heart rate initially recorded. * Age between 18 and 84 years old * Time between collapse and return of spontaneous circulation (ROSC) \< 60 min * Presumption, at the time of inclusion, of a possibility of starting Vent2Cool within a period of less than 120 min after ROSC. * Unconscious (GCS \<8, not able to obey verbal commands after sustained ROSC) * Patient affiliated with a social security system (If applicable) * Consent of the member of patients' family or that of the trusted person if present and able to understand; otherwise certificate of emergency inclusion in compliance with applicable regulations. * Vent2Cool must be connected to a standard cuffed ETT of 7.0 mm to 9.0 mm internal diameter for the procedure. Exclusion Criteria: * Conscious patient * Patient Ideal Body Weight less than 40 kgs or more than 93 kgs * Traumatic cardiac arrest, drowning, exsanguination, or sepsis * Temperature at admission \< 34.0°C * Need for veno-arterial extracorporeal circulation (Extracorporeal membrane of oxygenation, ECMO) before return of spontaneous circulation (refractory cardiac arrest) * One of the following signs at echocardiography at hospital admission: * Acute cor pulmonale, defined by right ventricular enlargement with interventricular septal deviation, associated with a Tricuspid Annular Plane Systolic Excursion (TAPSE) \< 12 mm and need for vasopressor agents * Time-velocity integral of subaortic flow \< 10 m/s * Wrong positioning or damage of the endotracheal tube. * Women under 50 years old (childbearing age) or for women of \>50 years old, a positive pregnancy test (urinary) in case of pregnancy suspicion by the investigator. Possible breastfeeding during the study. * Suspicion of intracranial bleeding * History of severe Chronic Obstructive Pulmonary Disease (COPD) with long-term home oxygen therapy * Acute respiratory pathology (pneumothorax, pleurisy, pneumonia, suspicion of contusion or intra-pulmonary hemorrhage following resuscitation) * COVID-19 positive test in case of clinical suspicion and/or epidemic context * Excessive mucus in the upper airways * Patient presenting at least one of the following criteria in the mechanical ventilation parameters at inclusion: * PEEP \> 8 cm H2O * Plateau pressure\> 25 cmH2O * Driving pressure\> 15cmH2O * Patient with at least one of the following criteria at inclusion: * PaO2\< 80 mmHg * PaO2 / FiO2\< 150 mmHg * PaCO2\> 48 mmHg

Primary outcome measure(s)

  • Success rate of the Vent2Cool procedure (safe induction of ultra-rapid therapeutic hypothermia) — From start of Vent2Cool procedure to 60min after
    The primary end point is the success of the procedure. The success of the procedure is defined as the ability to reach a body core temperature (bladder temperature recommended) of 33.0±0.5°C and a safe return to conventional mechanical ventilation within less than one hour after Vent2Cool start. Start of the Vent2Cool procedure is defined as the opening of the Vent2Cool patient connector valve.

Trial sites (1)

FacilityCityRegionStatus
Hopital Cochin - Service de Medecine intensive et reanimation au 27 rue du Faubourg Saint-Jacques Paris France

Other trials for the same condition

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Mean Arterial Pressure After Out-of-hospital Cardiac Arrest Recruiting
Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock. Recruiting
Targeted Temperature Management at 33°C Versus Controlled Normothermia for In-hospital Cardiac Arrest Recruiting
Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06798818 on ClinicalTrials.gov ↗ ← All trials in France