Prospective Validation of the ROX Index
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|ClinicalTrials.gov Identifier: NCT02845128|
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : August 12, 2019
|Condition or disease|
A growing interest in the non-invasive management of acute respiratory failure has been fuelled by the advent of high-flow nasal canula oxygen therapy (HFNC) and recent data showing that use of HFNC was associated with lower mortality, more ventilator-free days and lower risk for intubation in subsets of patients with PaO2/FIO2≤200mmHg or in those who were immunocompromised in comparison with non-invasive ventilation or standard oxygen. These positive results in favour of HFNC followed physiological studies indicating oxygenation and comfort improvements associated with HFNC use. This has led clinicians to try this technique in the most severe respiratory failure patients, those with ARDS.
Consubstantial to the increasing use of HFNC is the risk of delaying intubation. This is a major concern since a large body of evidence has shown that patients that fail non-invasive ventilatory management of de novo acute respiratory failure (ARF) have a worse outcome.
The variability in both the decision to intubate and its timing reported in several studies suggest that clinical parameters such as respiratory parameters alone are not sufficient and that the progression of the respiratory failure is not sufficiently taken into account. To address this need, we investigated a new score to identify patients at risk of intubation to help clinicians, with three goals simple to use, accurate, and immediately performable at the patients' bedside by any staff.
|Study Type :||Observational|
|Actual Enrollment :||191 participants|
|Official Title:||Prospective Validation of the ROX Index Utility in Predicting Failure of HFNC Treatment in Patients With Acute Respiratory Failure|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||September 2017|
requiring intubation and invasive mechanical ventilation
not requiring intubation nor invasive mechanical ventilation
- HFNC failure [ Time Frame: Through study completion (an average of 60 days) ]HFNC failure was defined as need for invasive mechanical ventilation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845128
|Hôpital Antoine Béclère, Service de Réanimation polyvalente et surveillance continue|
|Clamart, France, 92140|
|Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale|
|Colombes,, France, 92700|
|Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona|
|Barcelona, Spain, 08035|
|Hospital del Mar|
|Virgen de la Salud University Hospital|
|Study Director:||Oriol Roca, MD PhD||Vall d'Hebron University Hospital|