Individualization Flow in Patients Treated With High Flow Nasal Therapy (iFLOW)

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Lung Injury; Respiratory Failure; Oxygen Therapy; Acute Respiratory Failure; High-Flow Nasal Cannula

Treatments: Device: High Flow Nasal Cannula at 30L/min; Device: High Flow Nasal Cannula at 60L/min; Device: High Flow Nasal Cannula at 45L/min

Study type: Interventional

Funder types: Other

Identifiers

NCT05401474

PR(AG)21/2022

Details and patient eligibility

About

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).

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 3 patient groups

30 L/min

Active Comparator group

Description:

HFNC at 30L/min. FiO2 adjusted to reach SpO2 95%

Treatment:

Device: High Flow Nasal Cannula at 30L/min

45 L/min

Experimental group

Description:

HFNC at 45L/min. FiO2 adjusted to reach SpO2 95%

Treatment:

Device: High Flow Nasal Cannula at 45L/min

60 L/min

Experimental group

Description:

HFNC at 60L/min. FiO2 adjusted to reach SpO2 95%

Treatment:

Device: High Flow Nasal Cannula at 60L/min