Predicting HFNO failure within 72 hours using a physiology-informed model at 30 minutes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an ambispective, single-center observational study conducted at Ruijin Hospital in Shanghai. It first derived a dual-domain logistic model from baseline EFI, baseline PaCO2, and 0–30 minute changes in respiratory rate and SpO2 using retrospective data, then validated the model retrospectively with a later cohort, and is now prospectively validating it in an independent cohort. The primary outcome is endotracheal intubation within 72 hours of initiating high-flow nasal oxygen. Eligible adults have acute hypoxemic respiratory failure requiring HFNO, with several high-risk criteria, and must be able to undergo electrical impedance tomography monitoring. Exclusions include immediate intubation needs, neuromuscular limitation, pregnancy, contraindications to EIT, DNR orders, or hypercapnic respiratory failure as the primary diagnosis.

Why it matters

Who can join: the full rules

Inclusion Criteria (must meet all):

* Age ≥18 years
* Acute hypoxemic respiratory failure (AHRF) requiring HFNO initiation
* At least one of the following high-risk criteria: a) PaO₂/FiO₂ ≤200 mmHg or FiO₂ ≥0.40 to maintain SpO₂ ≥92%; b) Respiratory rate ≥25/min; c) APACHE II score ≥12; d) Bilateral infiltrates on chest imaging

Exclusion Criteria:

* Neuromuscular disease affecting spontaneous breathing
* Pregnancy
* Contraindication to EIT (e.g., chest wall wounds, pacemaker)
* Do-not-intubate order
* Hypercapnic respiratory failure as primary diagnosis (PaCO₂ \>50 mmHg with pH \<7.30 at baseline, unless mixed mechanism)

Where it's running

• Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: rui zhang, Dr
• Email: ccmzhangrui@foxmail.com
• Phone: 0086-021-21666066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.