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NCT04707729 · ClinicalTrials.gov registry record · NA

ROX Index for the Timing of Intubation in Nasal High Flow

A NA study of Acute Hypoxemic Respiratory Failure, sponsored by Hospital Universitari Vall d'Hebron Research Institute.

Recruiting
Registry status
NA
Development phase
630
Enrollment target
12
Study locations

NCT04707729 is a NA study of Acute Hypoxemic Respiratory Failure that is actively recruiting participants, run by Hospital Universitari Vall d'Hebron Research Institute. The registered enrollment target is 630 participants, below the 845-participant average among 5 other Acute Hypoxemic Respiratory Failure trials with a reported enrollment target (25% lower). The trial reports 12 study locations across 2 states.

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The verdict

NCT04707729, a NA study of Acute Hypoxemic Respiratory Failure, is actively recruiting participants, sponsored by Hospital Universitari Vall d'Hebron Research Institute.

RECRUITING
Registry status
NA
Development phase
630 participants
Enrollment target
12
Study locations

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

What the Registry Record Tells You About NCT04707729

The ClinicalTrials.gov registry entry for NCT04707729 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 845-participant average among 5 other Acute Hypoxemic Respiratory Failure trials with a reported enrollment target (25% lower). The listed sponsor is Hospital Universitari Vall d'Hebron Research Institute, which has 3 total studies on file at ClinicalTrials.gov.

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.

NCT04707729 reports 12 study locations spanning 2 distinct geographic areas - top geographies include Other, Illinois.

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.

What interventions are being tested in trial NCT04707729?

The interventions under investigation include: ROX index algorithm (DIAGNOSTIC_TEST).

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.

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.

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