Clinical trial NCT05401474: Individualization Flow in Patients Treated With High Flow Nasal Therapy (iFLOW)
Official title: Assessing Recruitability for Flow Individualization in Patients Treated With Nasal High Flow: a Physiological Study (The iFLOW Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High-Flow Nasal Cannula
Oxygen Therapy
Acute Respiratory Failure
Respiratory Failure
Lung Injury
Keywords: High-Flow Nasal Cannula
Oxygen therapy
Electrical Impedance Tomography
Lung injury
Acute Respiratory Failure
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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.

Primary outcomes:
measure: To validate the correlation between the change in ROX index and the change in EELV
timeFrame: 20 minutes
Secondary outcomes:
measure: 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).
timeFrame: 20 minutes
measure: 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).
timeFrame: 20 minutes
measure: To analyze the differences in SpO2 at different flows
timeFrame: 20 minutes
measure: To analyze the differences in respiratory rate at different flows
timeFrame: 20 minutes
measure: To analyze the differences in the FiO2 used at different flows
timeFrame: 20 minutes
measure: To analyze the differences in patient comfort at different flows, using the visual analogic scale (from 0 to 10)
timeFrame: 20 minutes.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
References:
citation: Ricard JD, Roca O, Lemiale V, Corley A, Braunlich J, Jones P, Kang BJ, Lellouche F, Nava S, Rittayamai N, Spoletini G, Jaber S, Hernandez G. Use of nasal high flow oxygen during acute respiratory failure. Intensive Care Med. 2020 Dec;46(12):2238-2247. doi: 10.1007/s00134-020-06228-7. Epub 2020 Sep 8.
citation: Mauri T, Alban L, Turrini C, Cambiaghi B, Carlesso E, Taccone P, Bottino N, Lissoni A, Spadaro S, Volta CA, Gattinoni L, Pesenti A, Grasselli G. Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31.
citation: 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.
citation: Bachmann MC, Morais C, Bugedo G, Bruhn A, Morales A, Borges JB, Costa E, Retamal J. Electrical impedance tomography in acute respiratory distress syndrome. Crit Care. 2018 Oct 25;22(1):263. doi: 10.1186/s13054-018-2195-6.