Validation Clinical Trial
Official title:
Prospective Validation of the ROX Index Utility in Predicting Failure of HFNC Treatment in Patients With Acute Respiratory Failure
NCT number | NCT02845128 |
Other study ID # | PR(AG)206/2016 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | September 2017 |
Verified date | March 2018 |
Source | Hospital Universitari Vall d'Hebron Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
We recently described the ROX index, defined as the ratio of SpO2/FIO2 to respiratory rate that outperformed the diagnostic accuracy of the two variables separately. Patients who had a ROX index ≥4.88 after 12 hours of HFNC therapy were less likely to be intubated, even after adjusting for potential covariates. Like any other scoring system, an independent validation of the score in a different population is necessary. We therefore undertook a multicenter, prospective study to validate the ROX index's diagnostic accuracy for determining which patients will fail on HFNC and will need to be intubated.
Status | Completed |
Enrollment | 191 |
Est. completion date | September 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All consecutive patients admitted to the ICU with pneumonia and treated with HFNC were included Exclusion Criteria: - Patients younger than 18 years old - Patients with indication for immediate intubation - Patients with limitation of therapeutic effort - Patients electively intubated for diagnostic or therapeutic procedures |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Antoine Béclère, Service de Réanimation polyvalente et surveillance continue | Clamart | |
France | Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale | Colombes, | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | Barcelona | |
Spain | Virgen de la Salud University Hospital | Toledo |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute |
France, Spain,
Frat JP, Ragot S, Coudroy R, Constantin JM, Girault C, Prat G, Boulain T, Demoule A, Ricard JD, Razazi K, Lascarrou JB, Devaquet J, Mira JP, Argaud L, Chakarian JC, Fartoukh M, Nseir S, Mercat A, Brochard L, Robert R, Thille AW; REVA network. Predictors of Intubation in Patients With Acute Hypoxemic Respiratory Failure Treated With a Noninvasive Oxygenation Strategy. Crit Care Med. 2018 Feb;46(2):208-215. doi: 10.1097/CCM.0000000000002818. — View Citation
Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Béduneau G, Delétage-Métreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17. — View Citation
Roca O, Messika J, Caralt B, García-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HFNC failure | HFNC failure was defined as need for invasive mechanical ventilation | Through study completion (an average of 60 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
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