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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
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:
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.

Condition or disease
Validation

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 191 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
HFNC failure
requiring intubation and invasive mechanical ventilation
HFNC success
not requiring intubation nor invasive mechanical ventilation



Primary Outcome Measures :
  1. HFNC failure [ Time Frame: Through study completion (an average of 60 days) ]
    HFNC failure was defined as need for invasive mechanical ventilation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the ICU with pneumonia and treated with HFNC were included
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
Hôpital Antoine Béclère, Service de Réanimation polyvalente et surveillance continue
Clamart, France, 92140
Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale
Colombes,, France, 92700
Spain
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Barcelona, Spain, 08035
Hospital del Mar
Barcelona, Spain
Virgen de la Salud University Hospital
Toledo, Spain
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Study Director: Oriol Roca, MD PhD Vall d'Hebron University Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02845128    
Other Study ID Numbers: PR(AG)206/2016
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
high-flow nasal cannula, HFNC, acute respiratory failure, intubation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases