ROX Index for the Timing of Intubation in Nasal High Flow

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Study ID
NCT04707729
Status
Recruiting
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Conditions

  • Acute Hypoxemic Respiratory Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • ROX index algorithm — DIAGNOSTIC_TEST
    The 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.

Study Details

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 Dates

Start date
Dec 9, 2020
Status verified
Jul 2024
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
630 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • No Intervention: Standard of care
    Patients will be intubated according to both the standard of care
  • Experimental: Standard of care + ROX algorithm
    In the intervention arm, patients will be intubated according to both the standard of care and the ROX index, whichever are met first. If the patient has a ROX index below different thresholds after different time-point within the first 12 hours since randomization, the NHF support will be increased to the maximum tolerated flow (up to 60L/min) and FIO2 of 1 and subsequently titrated with the target SpO2. Then, the ROX index will be recalculated in 30 minutes. If the patient is already treated with to 60L/min) and FIO2 of 1 and no further increase could be done, the ROX index will be recalculated after 30 minutes of full NHF support. Then: 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 30 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.

Primary Outcome Measure

Early intubation [ Time Frame: 12 hours since HFNC onset ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Chicago HospitalChicagoIllinois60612
Jie Li, MD PhD
[email protected]
Jie Li, MD PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Rush University Chicago Hospital· Chicago, IL

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