AIRCHILL · Product concept

One device. Ventilation and controlled cooling.

AIRCHILL is being developed as a transport ventilator with controlled respiratory cooling, for structured emergency-care workflows. It is not an approved product and carries no clinical outcome claim.

University Medical Center Hamburg-EppendorfBMBF Go-Bio 031A530Therapeutic Hypothermia and Temperature ManagementISMRM 2016 · Magna cum laude

Mechanism

Four controlled steps between the gas source and the patient.

The cooling capacity is not the interesting engineering problem. Control is: delivering a defined temperature without compromising ventilation, oxygenation, humidity or airway integrity.

1

Cold source

Oxygen-carrying gas stream or cryogenic source.

2

Thermal control

Controlled warming, mixing and humidification.

3

Ventilation

Defined temperature, flow, FiO₂ and pressure.

4

Heat extraction

Airway, lung and cerebral perfusion.

Laboratory demonstrator
Laboratory demonstrator

The demonstrator used in the preclinical experiments. Technology readiness is conservatively rated at TRL ≈ 4; the product architecture is not frozen.

Own photograph. TRL classified per the EU definition, Horizon Europe Annex G.

Thermal imaging during delivery
Thermal imaging during delivery

Infrared thermography at the start of cold air delivery and 23 minutes in. Surface temperature drops visibly; quantification gave roughly 0.3 °C per minute under endonasal delivery.

Final report, BMBF grant 031A530, University Medical Center Hamburg-Eppendorf, 2017.

MVP scope

A deliberately narrow first product.

The six-in-one platform remains the vision. The investable first step is smaller and can be approved.

In scope

The minimum viable product

Transport ventilation with controlled respiratory cooling · start together with established airway management · no cold volume bolus and no separate cooling catheter · interfaces to monitoring, documentation and telemedicine.

Deferred

Platform extensions

Suction, ECG and defibrillation and telemedicine are added after the MVP through OEM modules or interfaces. They are not part of the current product claim.

Clinical workflow

Designed for gated adoption, not for a shortcut.

Any clinical workflow needs inclusion criteria, airway-management rules, monitoring, stop criteria and training. Those belong in protocol, usability and risk-management work before routine use.

Before use

Eligibility and setup

Protocol-defined selection, device checks, trained operators.

During use

Ventilation and monitoring

Controlled intervention with respiratory, temperature and safety monitoring.

After use

Handover and follow-up

Documented transition into the receiving hospital’s temperature-control pathway.

Differentiation

Where we stand against RhinoChill — and where we do not.

What is defensible

Integration, safety data, timing

Cooling that runs on the ventilation already in place rather than as a second device. Preclinical airway safety for the endotracheal route is documented over six hours at −20 °C. RhinoChill works with perfluorohexane; our route does not.

What is not defensible

“Lower airway, therefore better”

Our own final report measured low, locally limited cooling performance for the endotracheal route because of dead-space ventilation, and recommended the endonasal route. Whoever switches or combines routes has to say so. The lower airway is a product objective, not a demonstrated advantage.

RhinoChill has carried a CE mark for commercial use, class IIb, since April 2011 (NICE MIB4). PRINCESS (Nordberg P et al., JAMA 2019;321:1677–1685, n = 677) missed its primary endpoint of good neurological outcome at 90 days. No CE-marked device was found that cools through the lower airway in combination with ventilation; the absence of a find is not proof, and EUDAMED and freedom-to-operate searches are outstanding.

Status

A development project — not an offer for clinical sale.

AIRCHILL is not presented here as CE-marked, FDA-cleared or available for routine patient treatment. Intended purpose, classification and claims remain subject to development, clinical evidence and regulatory review.

Ventilation, thermal systems, verification.

If you build emergency ventilators, thermal systems or airway consumables, we would like to talk.