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NCT04707729: ROX-1

ROX Index for the Timing of Intubation in Nasal High Flow

Recruiting now NA Last updated 15 August 2024
What this trial tests

NA trial testing ROX index algorithm in Acute Hypoxemic Respiratory Failure in 630 participants. Currently enrolling.

Timeline
9 December 2020
Primary endpoint
31 December 2024
30 June 2025

Quick facts

Lead sponsorHospital Universitari Vall d'Hebron Research Institute
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment630
Start date9 December 2020
Primary completion31 December 2024
Estimated completion30 June 2025
Sites12 locations across China, United States, Spain

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other recruiting trials for Acute Hypoxemic Respiratory Failure

Currently open trials in the same condition.

Other Hospital Universitari Vall d'Hebron Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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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