Back to resultsROX Index for the Timing of Intubation in Nasal High Flow (ROX-1)
Primary Purpose
Acute Hypoxemic Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ROX index algorithm
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Hypoxemic Respiratory Failure focused on measuring High flow nasal cannula, Nasal high flow, High flow oxygen therapy
Eligibility Criteria
Inclusion Criteria:
All consecutive patients older than 18 years with acute hypoxemic respiratory failure who need to be supported with nasal high flow (NHF) will be considered for inclusion.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital Universitari Vall d'HebronRecruiting
- Hospital del Mar
- Hospital Arnau de Vilanova
- Fundació AlthaiaRecruiting
- Hospital Son Espases
- Hospital Son Llàtzer
- Hospital Moisès BroggiRecruiting
- Hospital Mútua de Terrassa
- Hospital Virgen de la SaludRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of care
Standard of care + ROX algorithm
Arm Description
Patients will be intubated according to both the standard of care
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.
Outcomes
Primary Outcome Measures
Early intubation
Proportion of patients who will be intubated in the first 12 hours after inclusion between the two groups
Secondary Outcome Measures
Intubation rate
Rate of total intubations (early plus late)
28-day mortality
Mortality within the first 28 days since randomization
ICU mortality
Mortality in the ICU
Hospital mortality
Mortality in the hospital
Ventilator-free days within the first 28 days
Days free of mechanical ventilation in the first 28 days in those patients who needed to be intubated
Use of rescue treatments
Need for rescue therapies for refractory hypoxemia
Need for tracheotomy
Need for tracheotomy
ICU length of stay
Days admitted in the ICU
Hospital length of stay
Days admitted in the hospital
Rate of complications during tracheal intubation
Proportion of complications that appear during endotracheal intubation in those patients who fail
Full Information
NCT ID
NCT04707729
First Posted
December 24, 2020
Last Updated
January 11, 2021
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04707729
Brief Title
ROX Index for the Timing of Intubation in Nasal High Flow
Acronym
ROX-1
Official Title
ROX Index Compared to Standard of Care for the Timing of Intubation in Patients Supported by Nasal High Flow: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypoxemic Respiratory Failure
Keywords
High flow nasal cannula, Nasal high flow, High flow oxygen therapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
630 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Patients will be intubated according to both the standard of care
Arm Title
Standard of care + ROX algorithm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
ROX index algorithm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Early intubation
Description
Proportion of patients who will be intubated in the first 12 hours after inclusion between the two groups
Time Frame
12 hours since HFNC onset
Secondary Outcome Measure Information:
Title
Intubation rate
Description
Rate of total intubations (early plus late)
Time Frame
Through ICU length of stay, an average of 30 days
Title
28-day mortality
Description
Mortality within the first 28 days since randomization
Time Frame
28 days
Title
ICU mortality
Description
Mortality in the ICU
Time Frame
Through ICU length of stay, an average of 30 days
Title
Hospital mortality
Description
Mortality in the hospital
Time Frame
Through hospital length of stay, an average of 45 days
Title
Ventilator-free days within the first 28 days
Description
Days free of mechanical ventilation in the first 28 days in those patients who needed to be intubated
Time Frame
28 days since the intubation
Title
Use of rescue treatments
Description
Need for rescue therapies for refractory hypoxemia
Time Frame
Through ICU length of stay, an average of 30 days
Title
Need for tracheotomy
Description
Need for tracheotomy
Time Frame
Through ICU length of stay, an average of 30 days
Title
ICU length of stay
Description
Days admitted in the ICU
Time Frame
Through ICU length of stay, an average of 30 days
Title
Hospital length of stay
Description
Days admitted in the hospital
Time Frame
Through hospital length of stay, an average of 45 days
Title
Rate of complications during tracheal intubation
Description
Proportion of complications that appear during endotracheal intubation in those patients who fail
Time Frame
Through ICU length of stay, an average of 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All consecutive patients older than 18 years with acute hypoxemic respiratory failure who need to be supported with nasal high flow (NHF) will be considered for inclusion.
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oriol Roca, MD PhD
Phone
+34932746209
Email
oroca@vhebron.net
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrés Pacheco, MD
Email
andres_pacheco19@hotmail.com
First Name & Middle Initial & Last Name & Degree
Andrés Pacheco, MD
First Name & Middle Initial & Last Name & Degree
Marina García, MD
First Name & Middle Initial & Last Name & Degree
Oriol Roca, MD PhD
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Dot, MD
First Name & Middle Initial & Last Name & Degree
Joan R Masclans, MD PhD
First Name & Middle Initial & Last Name & Degree
Irene Dot, MD
Facility Name
Hospital Arnau de Vilanova
City
Lleida
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesús Caballero, MD
First Name & Middle Initial & Last Name & Degree
Jesús Caballero, MD
Facility Name
Fundació Althaia
City
Manresa
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carles Subirà, MD PhD
First Name & Middle Initial & Last Name & Degree
Carles Subirà, MD PhD
Facility Name
Hospital Son Espases
City
Palma De Mallorca
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireia Ferreruela, MD
First Name & Middle Initial & Last Name & Degree
Mireia Ferreruela, MD
Facility Name
Hospital Son Llàtzer
City
Palma De Mallorca
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gemma Rialp, MD PhD
First Name & Middle Initial & Last Name & Degree
Gemma Rialp, MD PhD
Facility Name
Hospital Moisès Broggi
City
Sant Joan Despí
ZIP/Postal Code
08970
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arantxa Mas, MD PhD
First Name & Middle Initial & Last Name & Degree
Arantxa Mas, MD PhD
First Name & Middle Initial & Last Name & Degree
Melinda Popoviciu, MD
First Name & Middle Initial & Last Name & Degree
Edgar Cortés, MD
Facility Name
Hospital Mútua de Terrassa
City
Terrassa
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Trenado, MD
First Name & Middle Initial & Last Name & Degree
Josep Trenado, MD
Facility Name
Hospital Virgen de la Salud
City
Toledo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gonzalo Hernández, MD PhD
First Name & Middle Initial & Last Name & Degree
Gonzalo Hernández, MD PhD
12. IPD Sharing Statement
Learn more about this trial
ROX Index for the Timing of Intubation in Nasal High Flow
We'll reach out to this number within 24 hrs