Individualization Flow in Patients Treated With High Flow Nasal Therapy (iFLOW)
NCT ID: NCT05401474
Last Updated: 2022-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
26 participants
INTERVENTIONAL
2022-03-18
2023-02-28
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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30 L/min
HFNC at 30L/min. FiO2 adjusted to reach SpO2 95%
High Flow Nasal Cannula at 30L/min
Flow will be set at 30L/min, FiO2 will be adjusted manually to maintain SpO2within the target range
45 L/min
HFNC at 45L/min. FiO2 adjusted to reach SpO2 95%
High Flow Nasal Cannula at 45L/min
Flow will be set at 45L/min, FiO2 will be adjusted manually to maintain SpO2within the target range
60 L/min
HFNC at 60L/min. FiO2 adjusted to reach SpO2 95%
High Flow Nasal Cannula at 60L/min
Flow will be set at 60L/min, FiO2 will be adjusted manually to maintain SpO2within the target range
Interventions
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High Flow Nasal Cannula at 30L/min
Flow will be set at 30L/min, FiO2 will be adjusted manually to maintain SpO2within the target range
High Flow Nasal Cannula at 45L/min
Flow will be set at 45L/min, FiO2 will be adjusted manually to maintain SpO2within the target range
High Flow Nasal Cannula at 60L/min
Flow will be set at 60L/min, FiO2 will be adjusted manually to maintain SpO2within the target range
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Locations
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Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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PR(AG)21/2022
Identifier Type: -
Identifier Source: org_study_id
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