ROX Index for the Timing of Intubation in Nasal High Flow

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    630
  • sponsor
    Hospital Universitari Vall d'Hebron Research Institute
Updated on 3 February 2021

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.

Details
Condition Acute Hypoxemic Respiratory Failure
Treatment ROX index algorithm
Clinical Study IdentifierNCT04707729
SponsorHospital Universitari Vall d'Hebron Research Institute
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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