Individualization Flow in Patients Treated With High Flow Nasal Therapy (iFLOW)
- Conditions
- Lung InjuryOxygen TherapyAcute Respiratory FailureRespiratory FailureHigh-Flow Nasal Cannula
- Interventions
- Device: High Flow Nasal Cannula at 30L/minDevice: High Flow Nasal Cannula at 45L/minDevice: High Flow Nasal Cannula at 60L/min
- Registration Number
- NCT05401474
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 26
- Adult patient admitted to the ICU requiring NHF due to AHRF that will be defined as an SpO2/FIO2 ratio <315
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 30 L/min High Flow Nasal Cannula at 30L/min HFNC at 30L/min. FiO2 adjusted to reach SpO2 95% 45 L/min High Flow Nasal Cannula at 45L/min HFNC at 45L/min. FiO2 adjusted to reach SpO2 95% 60 L/min High Flow Nasal Cannula at 60L/min HFNC at 60L/min. FiO2 adjusted to reach SpO2 95%
- Primary Outcome Measures
Name Time Method To validate the correlation between the change in ROX index and the change in EELV 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 Outcome Measures
Name Time Method To analyze the differences in respiratory rate at different flows 20 minutes Breaths/minute
To analyze the differences in SpO2 at different flows 20 minutes SpO2 by pulseoxymetry
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 Lung homogeneity as defined by global inhomogeneity index (GI) by EIT
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 Lung aeration as defined by the variable center of ventilation (CoV) in EIT.
To analyze the differences in the FiO2 used at different flows 20 minutes FiO2 will be titrated manually to achieve a predefined SpO2 range (92 - 96%; 88-92% for patients with chronic respiratory disease)
To analyze the differences in patient comfort at different flows, using the visual analogic scale (from 0 to 10) 20 minutes. Comfort score by visual analogic scale. From 0 (worst outcome) to 10 (best outocome).
Trial Locations
- Locations (1)
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain