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New treatment option for Acute Hypoxemic Respiratory Failure
Official title ROX Index for the Timing of Intubation in Nasal High Flow
ClinicalTrials.gov ID: NCT04707729
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- All consecutive patients older than 18 years with acute hypoxemic respiratory failure who need to be supported with nasal high flow (NHF) will be...
- Criteria for initiation of NHF if they had a respiratory rate \> 25 breaths/min and/or pulse oximetry (SpO2) \< 92% while receiving standard oxygen...
- Patients already treated with NHF for acute respiratory failure prior to ICU admission will be enrolled if duration of NHF prior to randomization...
You likely can't join if
- 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
See the full 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 treatment study with the same primary outcome.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Chongqing, China
- Shanghai, China
- Barcelona, Spain
- Ciudad Real, Spain
- Guadalajara, Spain
- Palma de Mallorca, Spain
- Sabadell, Spain
- Sant Joan Despí, Spain
- Toledo, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Chongqing, China; Shanghai, China; Barcelona, Spain; Ciudad Real, Spain; Guadalajara, Spain and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.