Clinical Trial

ROX Index for the Timing of Intubation in Nasal High Flow

Study acronym: ROX-1
Unknown
View on ClinicalTrials.gov →
Record status
This record was last updated August 15, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT04707729
Lead Sponsor Hospital Universitari Vall d'Hebron Research Institute
Conditions Acute Hypoxemic Respiratory Failure
Enrollment 630 participants
Start Date 2020-12-09
Primary Completion 2024-12-31 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-08-15