Actively Recruiting
ROX Index for the Timing of Intubation in Nasal High Flow
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2024-08-15
630
Participants Needed
12
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
ROX Index for the Timing of Intubation in Nasal High Flow
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years with acute hypoxemic respiratory failure requiring nasal high flow support
- Respiratory rate greater than 25 breaths per minute
- Blood oxygen level (SpO2) below 92% while receiving standard oxygen through a facemask at 10 liters per minute or more
- Patients already treated with nasal high flow for acute respiratory failure prior to ICU admission if treatment duration is less than one hour before randomization
You will not qualify if you...
- Patients younger than 18 years old
- Patients needing immediate intubation
- Patients treated with nasal high flow for more than one hour before randomization
- Patients with a do-not-intubate order
- Patients electively intubated for diagnostic or therapeutic procedures such as fibrobronchoscopy or surgery
- Patients without pulmonary infiltrates on chest X-ray
- Patients with post-extubation acute hypoxemic respiratory failure
- Patients receiving awake extracorporeal membrane oxygenation (ECMO)
- Pregnant patients
- Patients who refuse to participate or are in another interventional study with the same primary outcome
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Rush University Chicago Hospital
Chicago, Illinois, United States, 60612
Actively Recruiting
2
First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Not Yet Recruiting
3
The Second Military Medical University Hospital
Shanghai, China
Actively Recruiting
4
Zhongshan Hospital, Fudan University
Shanghai, China
Not Yet Recruiting
5
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
6
Hospital del Mar
Barcelona, Spain
Actively Recruiting
7
Hospital de Ciudad Real
Ciudad Real, Spain
Actively Recruiting
8
Hospital Civil Fray Antonio Alcalde
Guadalajara, Spain
Actively Recruiting
9
Hospital Son Llàtzer
Palma de Mallorca, Spain
Actively Recruiting
10
Hospital Parc Taulí
Sabadell, Spain
Actively Recruiting
11
Hospital Moisès Broggi
Sant Joan Despí, Spain, 08970
Actively Recruiting
12
Hospital Virgen de la Salud
Toledo, Spain
Actively Recruiting
Research Team
O
Oriol Roca, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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