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ROX Index for the Timing of Intubation in Nasal High Flow

Launched by HOSPITAL UNIVERSITARI VALL D'HEBRON RESEARCH INSTITUTE · Jan 11, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

High Flow Nasal Cannula Nasal High Flow High Flow Oxygen Therapy

ClinConnect Summary

The ROX-1 trial is studying a new way to help patients with acute hypoxemic respiratory failure (AHRF), a serious condition where the lungs struggle to get enough oxygen. This trial is testing a tool called the ROX index, which helps doctors decide when to intubate (place a tube in the windpipe to help with breathing) patients who are being treated with nasal high flow (NHF) oxygen. The goal is to see if using the ROX index can lead to earlier intubation for those who may not be responding well to NHF, potentially improving their chances of recovery.

To participate in this trial, patients need to be over 18 years old and experiencing AHRF that requires NHF support. They should have a fast breathing rate or low oxygen levels while receiving oxygen through a face mask. However, some patients may not be eligible, such as those who need immediate intubation, are younger than 18, or have a do-not-intubate order. Participants can expect close monitoring and care as part of the trial, and their progress will help researchers understand if the ROX index can improve outcomes for patients with this condition.

Gender

ALL

Eligibility criteria

  • 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.

About Hospital Universitari Vall D'hebron Research Institute

The Hospital Universitari Vall d'Hebron Research Institute (VHIR) is a leading biomedical research center affiliated with Vall d'Hebron University Hospital in Barcelona, Spain. Committed to advancing healthcare through innovative research, VHIR focuses on translating scientific discoveries into clinical applications, enhancing patient care and outcomes. The institute fosters collaboration among multidisciplinary teams of researchers, clinicians, and industry partners, emphasizing excellence in translational medicine, clinical trials, and public health initiatives. With a strong emphasis on ethical standards and patient safety, VHIR is dedicated to contributing to the global body of knowledge in various medical fields.

Locations

Barcelona, , Spain

Toledo, , Spain

Lleida, , Spain

Palma De Mallorca, , Spain

Barcelona, , Spain

Sabadell, , Spain

Terrassa, , Spain

Ciudad Real, , Spain

Palma De Mallorca, , Spain

Shanghai, , China

Chongqing, , China

Manresa, , Spain

Sant Joan Despí, , Spain

Chicago, Illinois, United States

Shanghai, , China

Guadalajara, , Spain

Patients applied

0 patients applied

Trial Officials

Oriol Roca, MD PhD

Principal Investigator

Universitat Autònoma de Barcelona (UAB)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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