NCT04707729 ROX Index for the Timing of Intubation in Nasal High Flow
| NCT ID | NCT04707729 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Condition | Acute Hypoxemic Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 630 participants |
| Start Date | 2020-12-09 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 630 participants in total. It began in 2020-12-09 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Oriol Roca, MD PhD
PRINCIPAL INVESTIGATOR
Universitat Autònoma de Barcelona (UAB)
Frequently Asked Questions
Who can join the NCT04707729 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Acute Hypoxemic Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04707729 currently recruiting?
Yes, NCT04707729 is actively recruiting participants. Contact the research team at oroca@tauli.cat for enrollment information.
Where is the NCT04707729 trial being conducted?
This trial is being conducted at Chicago, United States, Chongqing, China, Shanghai, China, Shanghai, China and 8 additional locations.
Who is sponsoring the NCT04707729 clinical trial?
NCT04707729 is sponsored by Hospital Universitari Vall d'Hebron Research Institute. The principal investigator is Oriol Roca, MD PhD at Universitat Autònoma de Barcelona (UAB). The trial plans to enroll 630 participants.