ROX Index for the Timing of Intubation in Nasal High Flow

Acute Hypoxemic Respiratory Failure Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707729
• Other study ID #: PR(AG)454/2020
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Oriol Roca, MD PhD
• Phone: +34932746209
• Email: oroca[@]vhebron.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 630
• Est. completion date: December 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

Diagnostic Test:
• ROX index algorithm
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 ?ROX is <0 the patient will be intubated; 2) if the ?ROX is 0-0.5, the ?ROX will be reassessed in 20 minutes; and 3) if the ?ROX 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.

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Arnau de Vilanova	Lleida
Spain	Fundació Althaia	Manresa
Spain	Hospital Son Espases	Palma De Mallorca
Spain	Hospital Son Llàtzer	Palma De Mallorca
Spain	Hospital Moisès Broggi	Sant Joan Despí
Spain	Hospital Mútua de Terrassa	Terrassa
Spain	Hospital Virgen de la Salud	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intubation rate	Rate of total intubations (early plus late)	Through ICU length of stay, an average of 30 days
Secondary	28-day mortality	Mortality within the first 28 days since randomization	28 days
Secondary	ICU mortality	Mortality in the ICU	Through ICU length of stay, an average of 30 days
Secondary	Hospital mortality	Mortality in the hospital	Through hospital length of stay, an average of 45 days
Secondary	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	28 days since the intubation
Secondary	Use of rescue treatments	Need for rescue therapies for refractory hypoxemia	Through ICU length of stay, an average of 30 days
Secondary	Need for tracheotomy	Need for tracheotomy	Through ICU length of stay, an average of 30 days
Secondary	ICU length of stay	Days admitted in the ICU	Through ICU length of stay, an average of 30 days
Secondary	Hospital length of stay	Days admitted in the hospital	Through hospital length of stay, an average of 45 days
Secondary	Rate of complications during tracheal intubation	Proportion of complications that appear during endotracheal intubation in those patients who fail	Through ICU length of stay, an average of 30 days