Assessing Recruitability for Flow Individualization in Patients Treated With Nasal High Flow: a Physiological Study (The iFLOW Study)
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- To validate the correlation between the change in ROX index and the change in EELV
Study Overview
Brief Summary
In patients with acute hypoxemic respiratory failure (AHRF), High Flow Nasal Therapy (HFNT) improves oxygenation, tolerance, and decreases work of breathing as compared to standard oxygen therapy by facemask.
The hypothesis is that this flow challenge (ROX index variation from 30 to 60L/min) could be used as a test for assessing changes in lung aeration, analyzed by the variation in end expiratory lung volume (ΔEELV), in patients treated with HFNC. It may allow to personalize the flow settings during HFNC. In this sense, an increase in EELV will be observed with higher flows in responders and, therefore, these participants may benefit from increasing the flow. In contrast, to increase the flow in non-responders (no significant increase in EELV with higher flows) increase the risk of patient self-inflicted lung injury (P-SILI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patient admitted to the ICU requiring NHF due to AHRF that will be defined as an SpO2/FIO2 ratio <315
Exclusion Criteria
- •Patient with indication for immediate CPAP, NIV, or invasive mechanical ventilation
- •Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h
- •Severe acidosis (pH ≤ 7.25)
- •Pregnant woman
- •Tracheotomised patient
- •Formalized ethical decision to withhold or withdraw life support
- •Patient under guardianship
- •Patient deprived of liberties
- •Patient already enrolled in the present study in a previous episode of acute respiratory failure
- •Patient who does not consent.
Arms & Interventions
30 L/min
HFNC at 30L/min. FiO2 adjusted to reach SpO2 95%
Intervention: High Flow Nasal Cannula at 30L/min (Device)
45 L/min
HFNC at 45L/min. FiO2 adjusted to reach SpO2 95%
Intervention: High Flow Nasal Cannula at 45L/min (Device)
60 L/min
HFNC at 60L/min. FiO2 adjusted to reach SpO2 95%
Intervention: High Flow Nasal Cannula at 60L/min (Device)
Outcomes
Primary Outcomes
To validate the correlation between the change in ROX index and the change in EELV
Time Frame: 20 minutes
Change in ROX is defined as the difference in ROX index (SpO2/FiO2/respiratory rate) between 2 flows. Change in EELV is the difference in End-Expiratory Lung Volume as determined by EIT.
Secondary Outcomes
- To analyze the differences in respiratory rate at different flows(20 minutes)
- To analyze the differences in SpO2 at different flows(20 minutes)
- To assess the changes in lung homogeneity (by the variable global inhomogeneity index (GI)) measured by EIT at differents flows (30L/min, 45 L/min and 60L/min).(20 minutes)
- To assess the changes in aeration distribution (by the variable center of ventilation (CoV)) measured by EIT at different flows (30L/min, 45 L/min and 60L/min).(20 minutes)
- To analyze the differences in the FiO2 used at different flows(20 minutes)
- To analyze the differences in patient comfort at different flows, using the visual analogic scale (from 0 to 10)(20 minutes.)