Status:
RECRUITING
ROX Index for the Timing of Intubation in Nasal High Flow
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Acute Hypoxemic Respiratory Failure
Eligibility:
All Genders
18-120 years
Phase:
NA
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 designe...
Detailed Description
This is a pilot study to assess whether the use of an algorithm incorporating the ROX index to traditional criteria for intubation in patients with AHRF supported with NHF is:(i) feasible; (ii) associ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT04707729
Start Date
December 9 2020
End Date
June 30 2025
Last Update
August 15 2024
Active Locations (12)
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1
Rush University Chicago Hospital
Chicago, Illinois, United States, 60612
2
First Affiliated Hospital of Chongqing Medical University
Chongqing, China
3
The Second Military Medical University Hospital
Shanghai, China
4
Zhongshan Hospital, Fudan University
Shanghai, China