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NCT04707729: ROX-1
ROX Index for the Timing of Intubation in Nasal High Flow
NA trial testing ROX index algorithm in Acute Hypoxemic Respiratory Failure in 630 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | Hospital Universitari Vall d'Hebron Research Institute |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 630 |
| Start date | 9 December 2020 |
| Primary completion | 31 December 2024 |
| Estimated completion | 30 June 2025 |
| Sites | 12 locations across China, United States, Spain |
Drugs / interventions tested
- ROX index algorithm
Conditions studied
- Acute Hypoxemic Respiratory Failure — all drugs for Acute Hypoxemic Respiratory Failure →
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Who can join
Adults 18 to 120, any sex, with Acute Hypoxemic Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Late or delayed intubation in patients with acute hypoxemic respiratory failure (AHRF) treated with nasal high flow (NHF) is associated with increased patient mortality. The ROX index has been designed and validated to predict outcome of NFH therapy by identifying those patients with a high risk of NHF failure and those with a high probability of success. Whether or not the ROX index may improve patient outcome remains to be shown. To do so, a strategy using the ROX index must lead to earlier intubation than commonly-used criteria. The objective of the ROX-1 trial is to assess whether the use of an algorithm incorporating the ROX index to standard of care for the time to intubation in patients with AHRF supported with NHF isassociated with an increase in the proportion of patients who are intubated within the first 12 hours among those patients who fail on NHF.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The use of high-flow nasal oxygen.
Maggiore SM, Grieco DL, Lemiale V. · · 2023 · cited 17× · PMID 37079086 · DOI 10.1007/s00134-023-07067-y -
Sepsis and acute respiratory failure in patients with cancer: how can we improve care and outcomes even further?
Lyons PG, McEvoy CA, Hayes-Lattin B. · · 2023 · cited 4× · PMID 37641516 · DOI 10.1097/mcc.0000000000001078
Verify or expand the search:
- PubMed search for NCT04707729
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07178483 — Evaluation of Physical Capacity and Energy Requirements in Patients With Hypoxemic Acute Respiratory Failure · active not recruiting
- NCT06815523 — Prediction of Duration of Mechanical Ventilation in Acute Hypoxemic Respiratoty Failure · active not recruiting
Other Hospital Universitari Vall d'Hebron Research Institute trials
Trials by the same sponsor.
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- NCT07281911 — Early Biological and Mechanical Profiling in Sepsis-Associated ARDS · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04707729 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute
- Last refreshed: 15 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04707729.
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