Using the ROX index to improve intubation timing in patients with respiratory failure
ROX Index Compared to Standard of Care for the Timing of Intubation in Patients Supported by Nasal High Flow: a Randomized Controlled Trial
This study is testing if using the ROX index can help doctors decide when to intubate patients with severe breathing problems who are on high flow oxygen, to see if it leads to better outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 630 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 12 sites (Chicago, Illinois and 11 other locations) |
| Trial ID | NCT04707729 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of the ROX index algorithm in determining the optimal timing for intubation in patients experiencing acute hypoxemic respiratory failure who are receiving nasal high flow oxygen therapy. It aims to compare the traditional criteria for intubation with the ROX index to see if earlier intubation can be achieved, potentially leading to better patient outcomes. The study is a multicenter, randomized controlled trial involving patients admitted to the intensive care unit. Participants will be monitored for their response to nasal high flow therapy and the timing of intubation will be assessed based on the ROX index.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with acute hypoxemic respiratory failure requiring nasal high flow support.
Not a fit: Patients who are younger than 18, have immediate intubation needs, or have a do-not-intubate order will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and outcomes for patients with acute hypoxemic respiratory failure.
How similar studies have performed: While the ROX index has been validated in previous studies, this specific application for improving intubation timing is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois and 11 other locations
- Rush University Chicago Hospital — Chicago, Illinois, United States (Recruiting)
- First Affiliated Hospital of Chongqing Medical University — Chongqing, China (Not_yet_recruiting)
- The Second Military Medical University Hospital — Shanghai, China (Recruiting)
- Zhongshan Hospital, Fudan University — Shanghai, China (Not_yet_recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital del Mar — Barcelona, Spain (Recruiting)
- Hospital de Ciudad Real — Ciudad Real, Spain (Recruiting)
- Hospital Civil Fray Antonio Alcalde — Guadalajara, Spain (Recruiting)
- Hospital Son Llàtzer — Palma de Mallorca, Spain (Recruiting)
- Hospital Parc Taulí — Sabadell, Spain (Recruiting)
- Hospital Moisès Broggi — Sant Joan Despí, Spain (Recruiting)
- Hospital Virgen de la Salud — Toledo, Spain (Recruiting)
Study contacts
- Principal investigator: Oriol Roca, MD PhD — Universitat Autònoma de Barcelona (UAB)
- Study coordinator: Oriol Roca, MD PhD
- Email: oroca@tauli.cat
- Phone: +34932746209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.