ROX Index for the Timing of Intubation in Nasal High Flow

Status unconfirmed · Not applicable

Conditions studied: Acute Hypoxemic Respiratory Failure

In brief

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.

Key facts

Study ID

NCT04707729

Run by

Hospital Universitari Vall d'Hebron Research Institute

People needed

630

Starts

2020-12-09

Expected to finish

2025-06-30

Last updated by the study team

2024-08-15

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All consecutive patients older than 18 years with acute hypoxemic respiratory failure who need to be supported with nasal high flow (NHF) will be considered for inclusion.
• Criteria for initiation of NHF if they had a respiratory rate > 25 breaths/min and/or pulse oximetry (SpO2) < 92% while receiving standard oxygen administered through a facemask at 10 L/mn or more.
• Patients already treated with NHF for acute respiratory failure prior to ICU admission will be enrolled if duration of NHF prior to randomization does not exceed one hour.

You may not qualify if…

• Patients younger than 18 years old.
• Patients with indication for immediate intubation.
• Patients treated with NHF for more than 1h prior to randomization.
• Patients with do-not-intubate order.
• Patients electively intubated for diagnostic or therapeutic procedures. (fibrobronchoscopy, surgery).
• Patients with no pulmonary infiltrates on chest X-ray
• Patient with post-extubation AHRF.
• Awake ECMO.
• Pregnancy.
• Refusal to participate or participation in another interventional study with the same primary outcome.

Where it is running

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

Full record on ClinicalTrials.gov

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