# AIRCHILL Schedule of Assessments & CRF Data Dictionary

> Shared Schedule of Assessments and eCRF/data dictionary for AIRCHILL cardiac-arrest and stroke clinical investigations.

- Canonical: https://www.medicalcooling.com/airchill-schedule-of-assessments-crf/
- Markdown: https://www.medicalcooling.com/airchill-schedule-of-assessments-crf/index.md
- Language: en-US
- Last modified: 2026-08-29T14:23:11+00:00

Shared clinical-operations module · v0.1

# Schedule of Assessments & CRF Data Dictionary

This shared module defines the minimum data structure for AIRCHILL-CA and AIRCHILL-STROKE. Indication-specific fields are flagged below. Final eCRFs should use controlled terminology, audit trails, edit checks, role-based access and validated electronic systems.

## Schedule of Assessments

AssessmentScreenRandomise / device start0–6 h24 h48–72 hDischarge30 d90 d

Eligibility / consent pathway●verify

Baseline demographics / history / pre-event function●

Randomisation / allocation●

Device configuration / software / serial●continuous change log

Patient-side gas temperature, humidity, flow, FiO₂, pressures, minute ventilationbaselinecontinuous / high-frequencysummaryas applicable

Core/systemic temperaturebaseline●continuous or protocol frequency●●●

Haemodynamics / ECG / vasopressorsbaseline●continuous / interval●●

ABG / gas exchangebaseline where availableprespecified intervals●as indicated

AE / SAE / device deficiencystartcontinuous●●through dischargereviewreview

Neurological outcomepre-event baselineearlyearly●optionalprimary blinded

EQ-5D-5L / resource use●●●

Stroke imaging core-lab fields●procedural24-h imaging

Cardiac-arrest CPR/ROSC/WLST fields●●●●●●●

## Core CRF modules

- Screening log: screening ID, site, date/time, eligibility, exclusion reason, consent route, randomised Y/N.
- Baseline: age, sex, height/weight, relevant history, medication, pre-event mRS/CPC, frailty where chosen.
- Event timeline: source-synchronised timestamps. CA: emergency call, witnessed status, bystander CPR, first rhythm, ROSC, airway, randomisation, AIRCHILL start. Stroke: last-known-well, door, imaging, anaesthesia, randomisation, device start, puncture, reperfusion.
- Device exposure: serial number, software, circuit, temperature setpoint/actual, humidity, FiO₂, flow, pressures, alarms, interruptions, reason, duration.
- Ventilation: mode, VT, RR, PEEP, plateau/peak pressure, compliance, minute ventilation, SpO₂, PaO₂, PaCO₂.
- Haemodynamics: HR, rhythm, MAP/SBP/DBP, vasopressors, fluids, major interventions.
- Safety: AE/SAE, onset, seriousness, severity, expectedness, causality to device/procedure, action, outcome, reporting dates.
- Device deficiency: failure, malfunction, use error, alarm, corrective action, whether SAE could have occurred.
- Outcome: mortality, cause/date; mRS/CPC; NIHSS for stroke; cognitive/participation measure where selected; blinded assessor details.
- Health economics: EMS resources, ICU/ward days, ventilation days, procedures, RRT, rehab, discharge destination, readmission, long-term care, EQ-5D-5L.

## Critical derived variables

- Randomisation-to-device-start.
- Event/ROSC or stroke-onset-to-device-start.
- Time to first measurable thermal effect.
- Cumulative respiratory thermal dose.
- Protocol-adherent exposure duration.
- Any reperfusion delay attributable to study intervention.
- Primary outcome completeness and assessor blinding status.

## Data-quality rules

All critical clocks must be synchronised; source hierarchy is predefined; units and ranges are standardised; impossible sequences trigger edit checks; device telemetry is preserved in raw form; post-randomisation edits require audit trail; endpoint adjudication fields are separated from treating-team fields.

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