Clinical operations · development plan v0.1

AIRCHILL Screening, Enrolment & Monitoring Plan

The monitoring strategy is risk-based: it concentrates verification on variables whose failure could materially affect participant safety, treatment timing, primary endpoints or regulatory credibility.

1. Site qualification

• Documented eligible-case volume and realistic screen-to-randomise estimate.
• 24/7 or protocol-compatible research/randomisation capability.
• Qualified ventilation/anaesthesia/EMS workflow and AIRCHILL training.
• Ability to capture high-resolution treatment timestamps and device telemetry.
• Blinded outcome assessment pathway.
• Stroke: thrombectomy volume, imaging-core transfer and anaesthesia integration.
• Cardiac arrest: EMS-hospital handover pathway, emergency-consent workflow and 90-day follow-up capacity.
• EMS ventilation/human-factors capability: ability to capture delivered and expired tidal volumes, ventilation rate, target-adherence, CPR strategy and the effect of user-facing feedback without allowing the study UI to compromise chest-compression or ventilation workflow. UTSW/AHA VENT-SIM (NCT07352709; updated 3 September 2026) is used as an external simulation benchmark rather than as evidence of clinical AIRCHILL benefit.

2. US public-data prescreen before site outreach

For US expansion, candidate centres/networks are prescreened with source-governed public data before questionnaires and run-in work. Stroke uses CMS cerebrovascular MS-DRG signals plus ClinicalTrials.gov neurovascular research activity, then confirms EVT/LVO/GA workflow locally. Cardiac arrest uses EMS/research-network activity and prospectively measured OHCA flow; CMS DRG 296 is never used as an OHCA denominator. TBI public-data signals may identify future neurotrauma partners but do not enter current CA/ST efficacy recruitment estimates. See US Clinical & Public Data Intelligence →.

3. Screening log

Every potentially eligible patient receives a screening identifier. Required fields: site, presentation date/time, principal eligibility features, exclusion criterion/reason, consent route, randomised Y/N, and reason eligible patients were not enrolled. Screening data are used to detect hidden selection bias and forecast recruitment.

4. Site activation

Activation requires ethics/regulatory approvals, contracts, investigator delegation log, device accountability setup, training completion, simulated randomisation/device-start drill, safety reporting test, outcome-blinding workflow and confirmation that the current device/software configuration matches the sponsor master list.

4. Monitoring critical-to-quality variables

• Informed/emergency consent compliance.
• Eligibility and exclusion criteria.
• Randomisation and treatment assignment.
• Device serial/software/circuit configuration.
• Randomisation-to-device-start and other critical clocks.
• Primary endpoint and blinded assessor identity.
• SAE / device deficiency / unanticipated effects.
• Stroke: puncture/reperfusion timestamps, eTICI, sICH, 24-h imaging.
• Cardiac arrest: ROSC timing, rhythm, neuroprognostication/WLST variables.

5. Central monitoring

Automated and statistical checks flag missing primary outcomes, implausible timelines, unusual enrolment patterns, protocol-drift, excessive device interruptions, site-specific safety rates, temperature/ventilation outliers, late safety reporting and treatment imbalance in co-interventions.

6. On-site / remote review

Source-data review is targeted rather than 100% blanket SDV. Early sites receive intensified review. Monitoring intensity increases after major deviations, safety signals, data-quality concerns or repeated timing failures.

7. Recruitment dashboards

Monthly site metrics include screened, eligible, randomised, eligibility fraction, eligible-not-enrolled reasons, randomised/month, device-start success, median start delay, protocol-adherent exposure, 90-day follow-up completeness and open queries.

8. Site performance actions

Sequence: feedback → retraining → corrective/preventive action → temporary enrolment pause → closure. A site that repeatedly cannot deliver the intended early exposure or—in stroke—causes study-related reperfusion delay should not compensate through higher low-quality enrolment.

9. Protocol deviations

Deviations are categorised as critical/major/minor according to impact on safety, rights, primary endpoint or treatment contrast. Critical deviations trigger immediate sponsor assessment and potential regulatory/ethics notification.

10. Close-out

Before site closure: complete primary follow-up, reconcile device/accountability records, resolve data queries, verify SAE/device deficiency reporting, archive essential documents and document investigational-device return/disposition.

11. Screening Log template

The sponsor maintains a controlled exclusion-reason code list and reviews eligible-not-enrolled cases centrally for selection bias.

← Clinical Investigation Package