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.
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.
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.
Parallel
ROX index algorithm
Diagnostic testThe thresholds of the ROX index for intubation are the following: * After 2 hours of HFNC: ROX \<2.85. * After 4 and 6 hours of HFNC: ROX \<3.47 * After 8, 10 and 12 hours of HFNC: ROX \<3.85 If the ROX index is between the abovementioned thresholds and 4.88, the NHF support will be also increased to the maximum tolerated flow (up to 60L/min) and FIO2 of 1 and subsequently titrated with the target SpO2. If the patient is already treated with to 60L/min) and FIO2 of 1 and no further increase could be done and the ROX index will be recalculated after 30 minutes of full NHF support. The ROX index will be recalculated in 30 minutes: 1) if the ΔROX is \<0 the patient will be intubated; 2) if the ΔROX is 0-0.5, the ΔROX will be reassessed in 20 minutes; and 3) if the ΔROX is \>0.5 the patient will not be intubated, NHF will be managed as protocolized and respiratory condition will be reassessed every two hours or at any new clinical deterioration.
Early intubation
Proportion of patients who will be intubated in the first 12 hours after inclusion between the two groups
Intubation rate
Rate of total intubations (early plus late)
28-day mortality
Mortality within the first 28 days since randomization
90-day mortality
Mortality within the first 90 days since randomization
ICU mortality
Mortality in the ICU
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