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

ConditionsCardiac Arrest Post Cardiac Arrest Syndrome

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-84

SponsorORIXHA

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: Treatment with Vent2Cool deviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Success rate of the Vent2Cool procedure (safe induction of ultra-rapid therapeutic hypothermia)

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.

Time frame

From start of Vent2Cool procedure to 60min after

Secondary outcomes

modified Rankin Scale (mRS)

mRS will be evaluated at Day 28. The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symptoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.

Time frame

At Day 28

Body Core Temperature

Core temperature (bladder recommended) at start of Vent2Cool procedure and for 36 h after the end of Vent2Cool procedure to include the maintenance and rewarming phases of TTM

Time frame

From start of Vent2Cool procedure to 37 hours after

Delay between the start of the Vent2Cool procedure and body core temperature of 33,5°C

Duration in minutes from start of the Vent2Cool procedure (i.e. opening of the Vent2Cool patient connector valve) to Body Core Temperature inferior or equal to 33,5 °C

Time frame

During the Vent2Cool procedure

Delay between return of spontaneous circulation (ROSC) and body core temperature of 33.5°C.

Duration in minutes from ROSC to body core temperature inferior or equal to 33,5 °C

Time frame

From ROSC to end of Vent2Cool procedure

Other outcomes

Cooling Rate in body core temperature

Cooling rate is expressed in °C/h and calculated as follows: temperature at start of Vent2Cool procedure - 33.5°C / duration to achieve a core temperature of 33.5°C

Time frame

During the Vent2Cool procedure

Occurence of cooling overshoot

Number and percentage of patients for whom the core temperature value is lower than 32°C and / or 30°C within 60 minutes after the start of the Vent2Cool procedure

Time frame

From start of Vent2Cool procedure to 60min after.

Early termination of the Vent2Cool procedure by the clinician before reaching a core target temperature below 33±0.5°C (failure of cooling induction)

Time frame

During the Vent2Cool procedure

modified Cardiac Arrest Hospital Prognosis (mCAHP) Score

Value of the modified Cardiac Arrest Hospital Prognosis (mCAHP) Score. Scores of either \<80; \[80; 105\[ or \>105 predict of risk of poor outcomes of respectively at least 40%, at least 80% or at least 95%.

Time frame

At inclusion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ORIXHA

Lead sponsor

Source ClinicalTrials.gov

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