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4 September 2026: new trial benchmarks for ventilation, peri-EVT physiology and device-based cooling

Evidence status: external registry and regulatory-development intelligence. These records do not establish AIRCHILL safety or efficacy.

VENT-SIM: ventilation performance becomes an explicit human-factors benchmark

The University of Texas Southwestern Medical Center and the American Heart Association are recruiting the VENT-SIM randomized crossover simulation study (NCT07352709; ClinicalTrials.gov record updated 3 September 2026). It tests real-time visual feedback during CPR and compares ventilation during 30:2 versus continuous-compression strategies. The primary outcome is the proportion of ventilations within the protocol target of 500–600 mL; inspired/expired volume and ventilation rate are secondary measures.

AIRCHILL implication: EMS human-factors and intra-arrest simulations should preserve delivered and expired tidal volume, ventilation rate, ventilation-target adherence and the CPR strategy in use. Cooling controls and feedback must be shown not to degrade the ventilation task.

Peri-EVT CO₂ modulation: PaCO₂ is a co-intervention, not background noise

NCT05051397, updated 3 September 2026, is prospectively testing moderate hypercapnia versus normocapnia during mechanically ventilated thrombectomy to influence collateral cerebral perfusion. Because CO₂ is a potent cerebral vasodilator, the AIRCHILL-STROKE programme now treats PaCO₂/EtCO₂ target, serial exposure and deviations as prespecified co-intervention variables.

AIRCHILL implication: a respiratory-cooling effect should not be confounded by systematic differences in ventilation-related CO₂ exposure between treatment groups.

CHILL-AP and Arctx: a useful regulatory and platform-development comparator

The CHILL-AP study (NCT07698119; record updated 3 September 2026) plans a 200-patient multicentre randomized trial of the Arctx Cool Catheter Set plus standard care versus standard care in acute pancreatitis. The catheter is connected to a commercial Blanketrol III heat-exchange system. The trial is described as supporting a future FDA marketing submission. Separately, the Arctx Cool Catheter Set received US 510(k) clearance K250632 in 2025 as a Class II esophageal thermal-regulation and gastric-suction device.

AIRCHILL implication: the programme can use this as an external development benchmark for two principles already central to AIRCHILL: reuse qualified platform hardware where appropriate, and keep performance/temperature-management evidence distinct from a later disease-specific clinical outcome claim. This does not establish predicate equivalence, Freedom to Operate or AIRCHILL’s regulatory route.

What changed on MedicalCooling.com

  • The cardiac-arrest CIP, SoA/CRF and human-factors pipeline now capture CPR ventilation strategy, inspired/expired volume and real-time feedback as explicit operational variables.
  • The stroke CIP, SAP and SoA/CRF now prespecify PaCO₂/EtCO₂ exposure and deviations as a peri-EVT co-intervention.
  • The translational pipeline now records CHILL-AP/Arctx as an external platform/regulatory-development comparator with explicit non-equivalence caveats.
  • The research register contains a dated live-intelligence addendum while preserving the older frozen corpus snapshot.

Sources: ClinicalTrials.gov NCT07352709, NCT05051397 and NCT07698119; US FDA 510(k) K250632. Registry status is sponsor-submitted and may change.