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

Assessing Recruitability for Flow Individualization in Patients Treated With Nasal High Flow: a Physiological Study (The iFLOW Study)

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 Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Lung Injury; Acute Respiratory Failure; Oxygen Therapy; High-Flow Nasal Cannula
• Intervention / Treatment: Device: High Flow Nasal Cannula at 30L/min; Device: High Flow Nasal Cannula at 45L/min; Device: High Flow Nasal Cannula at 60L/min

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francisco Ramos, MD; Phone Number: +34932746209; Email: f.ramos@vhebron.net

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
    • Contact: Francisco Ramos, MD; Phone Number: +34932746209; Email: f.ramos@vhebron.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 30 L/min; HFNC at 30L/min. FiO2 adjusted to reach SpO2 95%	Device: 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
EXPERIMENTAL: 45 L/min; HFNC at 45L/min. FiO2 adjusted to reach SpO2 95%	Device: 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
EXPERIMENTAL: 60 L/min; HFNC at 60L/min. FiO2 adjusted to reach SpO2 95%	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To validate the correlation between the change in ROX index and the change in EELV	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.	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Lung aeration as defined by the variable center of ventilation (CoV) in EIT.	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).	Lung homogeneity as defined by global inhomogeneity index (GI) by EIT	20 minutes
To analyze the differences in SpO2 at different flows	SpO2 by pulseoxymetry	20 minutes
To analyze the differences in respiratory rate at different flows	Breaths/minute	20 minutes
To analyze the differences in the FiO2 used at different flows	FiO2 will be titrated manually to achieve a predefined SpO2 range (92 - 96%; 88-92% for patients with chronic respiratory disease)	20 minutes
To analyze the differences in patient comfort at different flows, using the visual analogic scale (from 0 to 10)	Comfort score by visual analogic scale. From 0 (worst outcome) to 10 (best outocome).	20 minutes.

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2022
• Primary Completion (ANTICIPATED): November 5, 2022
• Study Completion (ANTICIPATED): February 28, 2023

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (ACTUAL): June 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Oxygen therapy; High-Flow Nasal Cannula; Electrical Impedance Tomography; Lung injury; Acute Respiratory Failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Respiratory Insufficiency; Lung Injury
• Other Study ID Numbers: PR(AG)21/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No