ROX Index for the Timing of Intubation in Nasal High Flow

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.

Conditions

Acute Hypoxemic Respiratory Failure

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Study Overview

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Study Details

Study overview

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.

ROX Index Compared to Standard of Care for the Timing of Intubation in Patients Supported by Nasal High Flow: a Randomized Controlled Trial

ROX Index for the Timing of Intubation in Nasal High Flow

Condition
Acute Hypoxemic Respiratory Failure
Intervention / Treatment

-

Contacts and Locations

Chicago

Rush University Chicago Hospital, Chicago, Illinois, United States, 60612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 120 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hospital Universitari Vall d'Hebron Research Institute,

Oriol Roca, MD PhD, PRINCIPAL_INVESTIGATOR, Universitat Autònoma de Barcelona (UAB)

Study Record Dates

2025-06-30