# AIRCHILL-STROKE Full Clinical Investigation Plan

> Full development Clinical Investigation Plan for peri-EVT AIRCHILL in intubated large-vessel-occlusion ischaemic stroke.

- Canonical: https://www.medicalcooling.com/cip-airchill-ischaemic-stroke/
- Markdown: https://www.medicalcooling.com/cip-airchill-ischaemic-stroke/index.md
- Language: en-US
- Last modified: 2026-08-29T14:22:44+00:00

CIP · development draft v0.1

# AIRCHILL-STROKE Clinical Investigation Plan

Operational CIP for peri-EVT AIRCHILL in adults with anterior-circulation LVO who already require general anaesthesia and invasive ventilation. The protocol explicitly prohibits delaying arterial puncture or reperfusion for study treatment.

## 1. Administrative information

Sponsor: to be designated. Protocol: AIRCHILL-STROKE. Device: AIRCHILL investigational ventilation/cooling system. Version: development v0.1. Stages: ST-1 feasibility → ST-2 signal finding → ST-3 confirmatory.

## 2. Objective

Determine whether very early respiratory cooling delivered around thrombectomy improves 90-day functional outcome while preserving anaesthesia, haemodynamics and EVT speed/quality.

## 3. Design

Prospective multicentre randomised controlled open-treatment, blinded-endpoint investigation. Central 1:1 allocation before arterial puncture or at the earliest feasible peri-EVT point.

## 4. Population

Adults with acute anterior-circulation LVO selected for EVT who require general anaesthesia and invasive ventilation for clinical reasons independent of research participation.

### Draft inclusion

- Age ≥18 years.
- Protocol-defined anterior-circulation LVO eligible for EVT.
- General anaesthesia/invasive ventilation clinically indicated.
- Imaging profile within final ASPECTS/core/penumbra criteria.
- Randomisation within the final early/extended time window.
- Permitted consent pathway available.

### Draft exclusion

- Primary intracranial haemorrhage.
- Severe pre-stroke disability above the final locked threshold.
- Refractory haemodynamic or respiratory instability incompatible with study gas delivery.
- Terminal illness or clear non-survivable condition.
- Device-specific contraindication.
- Any circumstance in which study procedures would delay reperfusion.

## 5. Intervention

AIRCHILL begins after airway security and is integrated in parallel with anaesthesia and EVT preparation. Device setup must not extend door-to-puncture or puncture-to-reperfusion intervals. The final dose is defined by patient-side temperature, humidity, FiO₂, flow/minute ventilation, pressures and duration.

## 6. Comparator

Standard EVT, anaesthesia, ventilation and temperature management without active AIRCHILL respiratory cooling.

## 7. Schedule of assessments

Screening/imaging; pre-randomisation baseline; randomisation/device start; continuous peri-procedural device and physiological data; puncture; reperfusion; immediate post-EVT; 2–6 h; 24 h imaging/NIHSS; 48–72 h; discharge; 30 d; 90 d blinded mRS/EQ-5D. Shared detailed matrix: [SoA / CRF](https://www.medicalcooling.com/airchill-schedule-of-assessments-crf/).

## 8. Endpoints

Primary ST-3: blinded ordinal 90-day mRS shift. Key secondary: mortality, mRS 0–2 and 0–1, NIHSS, EQ-5D-5L, symptomatic ICH, malignant oedema/decompressive surgery, ICU/hospital stay. ST-2 imaging: final infarct volume, infarct growth, penumbral salvage where available, oedema metrics. Procedural: puncture-to-reperfusion, eTICI, passes, rescue treatment. Safety: device-related SAE, ventilation/gas-exchange compromise, haemodynamic events, arrhythmia, pneumonia and any study-attributable EVT delay.

## 9. Randomisation/blinding

Central concealed 1:1 randomisation, variable blocks, limited stratification by site and key baseline severity/time-window variables. Treating team unblinded; 90-day mRS assessor and imaging core laboratory blinded.

## 10. Sample size

Working ST-3 anchor: ~1,600 participants for common OR ~1.35. ~1,300 for OR ~1.40; >2,000 may be required for OR ~1.30. Final simulation uses ST-2 AIRCHILL mRS distributions, the final covariates/estimand, missingness and interim design.

## 11. Statistics

ITT primary analysis using proportional-odds ordinal logistic regression, with prespecified assumption checks and robust sensitivity analysis. Imaging analyses use blinded core-lab continuous endpoints with strategies preventing survivorship bias. See [SAP](https://www.medicalcooling.com/airchill-statistical-analysis-plan/).

## 12. DSMB and stopping

Independent DSMB reviews respiratory/device safety, haemodynamics, symptomatic ICH, mortality, malignant oedema and any treatment-attributable delay in puncture/reperfusion. Formal ST-3 efficacy/futility interim near 50% information is planned subject to final statistical design. See [DSMB Charter](https://www.medicalcooling.com/airchill-dsmb-charter/).

## 13. Monitoring

Critical data include eligibility, baseline imaging, consent, randomisation, device configuration/start, arterial puncture/reperfusion timestamps, eTICI, 24-h imaging, SAE/device deficiency and 90-day mRS. Central monitoring flags treatment delays and site-specific workflow drift. See [operations plan](https://www.medicalcooling.com/airchill-screening-monitoring-plan/).

## 14. Ethics

No participant is intubated solely for AIRCHILL. Consent follows local prospective representative or emergency/deferred pathways, with participant consent if capacity returns.

## 15. Go/no-go

ST-2 must show acceptable safety, no material EVT delay, reproducible thermal separation, coherent imaging/early neurological signal and a 90-day mRS distribution supporting a feasible pivotal trial.

[← Clinical Investigation Package](https://www.medicalcooling.com/airchill-clinical-investigation-package/)