NCT02845128

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 12, 2019

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

July 5, 2016

Last Update Submit

August 9, 2019

Conditions

Validation

Keywords

high-flow nasal cannula, HFNC, acute respiratory failure, intubation

Outcome Measures

Primary Outcomes (1)

  • HFNC failure

    HFNC failure was defined as need for invasive mechanical ventilation

    Through study completion (an average of 60 days)

Study Arms (2)

HFNC failure

requiring intubation and invasive mechanical ventilation

HFNC success

not requiring intubation nor invasive mechanical ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the ICU with pneumonia and treated with HFNC were included

You may qualify if:

  • \- All consecutive patients admitted to the ICU with pneumonia and treated with HFNC were included

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Antoine Béclère, Service de Réanimation polyvalente et surveillance continue

Clamart, 92140, France

Location

Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale

Colombes, 92700, France

Location

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Barcelona, 08035, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Virgen de la Salud University Hospital

Toledo, Spain

Location

Related Publications (4)

  • Roca O, Messika J, Caralt B, Garcia-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.

    PMID: 27481760BACKGROUND

  • 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.

    PMID: 29099420BACKGROUND

  • 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, Beduneau G, Deletage-Metreau 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.

    PMID: 25981908BACKGROUND

  • Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.

    PMID: 30576221DERIVED

Study Officials

  • Oriol Roca, MD PhD

    Vall d'Hebron University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 27, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

August 12, 2019

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)FR(2)