ROX Index for the Timing of Intubation in Nasal High Flow

NCT04707729 | Recruiting

• 1 other identifier: PR(AG)454/2020
• Study Type: interventional
• Target: 630
• Locations: 3 countries
• Sites: 12

Brief Summary

Late or delayed intubation in patients with acute hypoxemic respiratory failure (AHRF) treated with nasal high flow (NHF) is associated with increased patient mortality. The ROX index has been designed and validated to predict outcome of NFH therapy by identifying those patients with a high risk of NHF failure and those with a high probability of success. Whether or not the ROX index may improve patient outcome remains to be shown. To do so, a strategy using the ROX index must lead to earlier intubation than commonly-used criteria. The objective of the ROX-1 trial is to assess whether the use of an algorithm incorporating the ROX index to standard of care for the time to intubation in patients with AHRF supported with NHF isassociated with an increase in the proportion of patients who are intubated within the first 12 hours among those patients who fail on NHF.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

High flow nasal cannula; Nasal high flow; High flow oxygen therapy

Outcome Measures

Primary Outcomes (1)

• Early intubation

  Proportion of patients who will be intubated in the first 12 hours after inclusion between the two groups

  12 hours since HFNC onset

Secondary Outcomes (12)

• Intubation rate

  Through ICU length of stay, an average of 30 days

• 28-day mortality

  28 days

• 90-day mortality

  90 days

• ICU mortality

  Through ICU length of stay, an average of 30 days

• Hospital mortality

  Through hospital length of stay, an average of 45 days

Study Arms (2)

Standard of care

NO INTERVENTION

Patients will be intubated according to both the standard of care

Standard of care + ROX algorithm

EXPERIMENTAL

In the intervention arm, patients will be intubated according to both the standard of care and the ROX index, whichever are met first. If the patient has a ROX index below different thresholds after different time-point within the first 12 hours since randomization, the NHF support will be increased to the maximum tolerated flow (up to 60L/min) and FIO2 of 1 and subsequently titrated with the target SpO2. Then, the ROX index will be recalculated in 30 minutes. If the patient is already treated with to 60L/min) and FIO2 of 1 and no further increase could be done, the ROX index will be recalculated after 30 minutes of full NHF support. Then: 1) if the ΔROX is \<0 the patient will be intubated; 2) if the ΔROX is 0-0.5, the ΔROX will be reassessed in 30 minutes; and 3) if the ΔROX is \>0.5 the patient will not be intubated, NHF will be managed as protocolized and respiratory condition will be reassessed every two hours or at any new clinical deterioration.

Diagnostic Test: ROX index algorithm

Interventions

ROX index algorithm DIAGNOSTIC_TEST

The thresholds of the ROX index for intubation are the following: * After 2 hours of HFNC: ROX \<2.85. * After 4 and 6 hours of HFNC: ROX \<3.47 * After 8, 10 and 12 hours of HFNC: ROX \<3.85 If the ROX index is between the abovementioned thresholds and 4.88, the NHF support will be also increased to the maximum tolerated flow (up to 60L/min) and FIO2 of 1 and subsequently titrated with the target SpO2. If the patient is already treated with to 60L/min) and FIO2 of 1 and no further increase could be done and the ROX index will be recalculated after 30 minutes of full NHF support. The ROX index will be recalculated in 30 minutes: 1) if the ΔROX is \<0 the patient will be intubated; 2) if the ΔROX is 0-0.5, the ΔROX will be reassessed in 20 minutes; and 3) if the ΔROX is \>0.5 the patient will not be intubated, NHF will be managed as protocolized and respiratory condition will be reassessed every two hours or at any new clinical deterioration.

Standard of care + ROX algorithm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Criteria for initiation of NHF if they had a respiratory rate \> 25 breaths/min and/or pulse oximetry (SpO2) \< 92% while receiving standard oxygen administered through a facemask at 10 L/mn or more.
• Patients already treated with NHF for acute respiratory failure prior to ICU admission will be enrolled if duration of NHF prior to randomization does not exceed one hour.

You may not qualify if:

• Patients younger than 18 years old.
• Patients with indication for immediate intubation.
• Patients treated with NHF for more than 1h prior to randomization.
• Patients with do-not-intubate order.
• Patients electively intubated for diagnostic or therapeutic procedures. (fibrobronchoscopy, surgery).
• Patients with no pulmonary infiltrates on chest X-ray
• Patient with post-extubation AHRF.
• Awake ECMO.
• Pregnancy.
• Refusal to participate or participation in another interventional study with the same primary outcome.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (12)

Rush University Chicago Hospital

Chicago, Illinois, 60612, United States

RECRUITING

First Affiliated Hospital of Chongqing Medical University

Chongqing, China

NOT YET RECRUITING

The Second Military Medical University Hospital

Shanghai, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, China

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital de Ciudad Real

Ciudad Real, Spain

RECRUITING

Hospital Civil Fray Antonio Alcalde

Guadalajara, Spain

RECRUITING

Hospital Son Llàtzer

Palma de Mallorca, Spain

RECRUITING

Hospital Parc Taulí

Sabadell, Spain

RECRUITING

Hospital Moisès Broggi

Sant Joan Despí, 08970, Spain

RECRUITING

Hospital Virgen de la Salud

Toledo, Spain

RECRUITING

Related Publications (3)

• Brochard L, Mancebo J, Wysocki M, Lofaso F, Conti G, Rauss A, Simonneau G, Benito S, Gasparetto A, Lemaire F, et al. Noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1995 Sep 28;333(13):817-22. doi: 10.1056/NEJM199509283331301.

  PMID: 7651472 BACKGROUND

• 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: 30576221 BACKGROUND

• 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: 27481760 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Oriol Roca, MD PhD

  Universitat Autònoma de Barcelona (UAB)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oriol Roca, MD PhD

CONTACT

+34932746209; oroca@tauli.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The ROX-1 trial is an international, multicenter, parallel, open-label randomized controlled two-arm trial that will be performed in patients with AHRF, supported by nasal high flow, who are admitted to the intensive care unit (ICU). Patients will be randomized after stratification according to PaO2/FiO2, through an online automatic centralized and computerized system to one of the study groups (1:1 ratio): traditional intubation criteria or traditional intubation criteria + ROX criteria.

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: January 13, 2021
• Study Start: December 9, 2020
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-07

Locations

CN (3); ES (8); US (1)