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RECRUITING NA

ROX Index for the Timing of Intubation in Nasal High Flow

NCT04707729 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DIAGNOSTIC_TEST ROX index algorithm

Study Locations (12)

Other

  • First Affiliated Hospital of Chongqing Medical University — Chongqing
  • The Second Military Medical University Hospital — Shanghai
  • Zhongshan Hospital, Fudan University — Shanghai
  • Hospital Universitari Vall d'Hebron — Barcelona
  • Hospital del Mar — Barcelona
  • Hospital de Ciudad Real — Ciudad Real
  • Hospital Civil Fray Antonio Alcalde — Guadalajara
  • Hospital Son Llàtzer — Palma de Mallorca
  • Hospital Parc Taulí — Sabadell
  • Hospital Moisès Broggi — Sant Joan Despí
  • Hospital Virgen de la Salud — Toledo

Illinois

  • Rush University Chicago Hospital — Chicago

Trial Details

FieldValue
Enrollment Target 630 participants
Start Date 2020-12-09
Est. Completion 2025-06-30
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04707729

The ClinicalTrials.gov registry entry for NCT04707729 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital Universitari Vall d'Hebron Research Institute, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acute Hypoxemic Respiratory Failure appearing as the primary indexed condition, and to 1 intervention — of which ROX index algorithm is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04707729 reports 12 study locations spanning 2 distinct geographic areas — top geographies include Other, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04707729 about?

NCT04707729 is a clinical study titled "ROX Index for the Timing of Intubation in Nasal High Flow". 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 ...

What is the current status of trial NCT04707729?

This trial is currently recruiting. It is a NA study. The enrollment target is 630 participants. The study started on 2020-12-09. Estimated completion is 2025-06-30.

What conditions does trial NCT04707729 study?

This clinical trial studies the following conditions: Acute Hypoxemic Respiratory Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04707729?

The interventions under investigation include: ROX index algorithm (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04707729?

This trial is sponsored by Hospital Universitari Vall d'Hebron Research Institute, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04707729 being conducted?

This trial has 12 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial