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

NCT06798818 | Not Yet Recruiting DMC

• 2 other identifiers: AR23_0007CIV-24-02-046114
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Arrest; Post Cardiac Arrest Syndrome

Keywords

Cooling; Targeted Temperature Management; ROSC; Resuscitated Cardiac Arrest; Out of Hospital cardiac arrest; Therapeutic Hypothermia; liquid ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of Vent2Cool procedure to 60min after

Secondary Outcomes (7)

• modified Rankin Scale (mRS)

  At Day 28

• Body Core Temperature

  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

  During the Vent2Cool procedure

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

  From ROSC to end of Vent2Cool procedure

• PaO2 and PaCO2

  Inclusion, 10 min and 25 min after start of Vent2Cool procedure

Other Outcomes (26)

• Cooling Rate in body core temperature

  During the Vent2Cool procedure

• Occurence of cooling overshoot

  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)

  During the Vent2Cool procedure

Study Arms (1)

Treatment with Vent2Cool device

EXPERIMENTAL

Vent2Cool is to be used to perform induction of Ultra-Rapid Therapeutic Hypothermia for the patients. The hypothermia maintenance and rewarming phases will be performed with an external TTM device as currently used in the investigation centres.

Device: Ultra-rapid therapeutic hypothermia induction by total liquid ventilation

Interventions

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 with Vent2Cool device

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Unconscious (GCS \<8, not able to obey verbal commands after sustained ROSC)
• Patient affiliated with a social security system (If applicable)
• Vent2Cool must be connected to a standard cuffed ETT of 7.0 mm to 9.0 mm internal diameter for the procedure.

You may not qualify if:

• 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

Sponsors & Collaborators

• ORIXHA: lead

Study Sites (1)

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

Paris, 75014, France

Location

MeSH Terms

Conditions

Heart Arrest; Post-Cardiac Arrest Syndrome; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Reperfusion Injury; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sandrine Perrotto, PhD

CONTACT

+33187666102; clinical.affairs@orixha.com

Fabrice Paublant

CONTACT

+33660767729; paublant@orixha.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 29, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

FR (1)