Prospective Validation of the ROX Index

Validation Clinical Trial

Official title:

Prospective Validation of the ROX Index Utility in Predicting Failure of HFNC Treatment in Patients With Acute Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845128
• Other study ID #: PR(AG)206/2016
• Status: Completed
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2018
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Respiratory Insufficiency
• Validation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Countries where clinical trial is conducted

France,  Spain, 

References & Publications (3)

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

Outcome

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)