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

Primary Purpose

High-Flow Nasal Cannula, Oxygen Therapy, Acute Respiratory Failure

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

High Flow Nasal Cannula at 30L/min

High Flow Nasal Cannula at 45L/min

High Flow Nasal Cannula at 60L/min

About this trial

This is an interventional supportive care trial for High-Flow Nasal Cannula focused on measuring High-Flow Nasal Cannula, Oxygen therapy, Electrical Impedance Tomography, Lung injury, Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hospital Universitari Vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

30 L/min

45 L/min

60 L/min

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

To analyze the differences in SpO2 at different flows

SpO2 by pulseoxymetry

To analyze the differences in respiratory rate at different flows

Breaths/minute

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)

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).

Full Information

NCT ID

NCT05401474

First Posted

April 5, 2022

Last Updated

May 27, 2022

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05401474

Brief Title

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

Acronym

iFLOW

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 18, 2022 (Actual)

Primary Completion Date

November 5, 2022 (Anticipated)

Study Completion Date

February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

30 L/min

Arm Type

Active Comparator

Arm Description

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

Arm Title

45 L/min

Arm Type

Experimental

Arm Description

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

Arm Title

60 L/min

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

High Flow Nasal Cannula at 30L/min

Intervention Description

Flow will be set at 30L/min, FiO2 will be adjusted manually to maintain SpO2within the target range

Intervention Type

Device

Intervention Name(s)

High Flow Nasal Cannula at 45L/min

Intervention Description

Flow will be set at 45L/min, FiO2 will be adjusted manually to maintain SpO2within the target range

Intervention Type

Device

Intervention Name(s)

High Flow Nasal Cannula at 60L/min

Intervention Description

Flow will be set at 60L/min, FiO2 will be adjusted manually to maintain SpO2within the target range

Primary Outcome Measure Information:

Title

To validate the correlation between the change in ROX index and the change in EELV

Description

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.

Time Frame

20 minutes

Secondary Outcome Measure Information:

Title

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).

Description

Lung aeration as defined by the variable center of ventilation (CoV) in EIT.

Time Frame

20 minutes

Title

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).

Description

Lung homogeneity as defined by global inhomogeneity index (GI) by EIT

Time Frame

20 minutes

Title

To analyze the differences in SpO2 at different flows

Description

SpO2 by pulseoxymetry

Time Frame

20 minutes

Title

To analyze the differences in respiratory rate at different flows

Description

Breaths/minute

Time Frame

20 minutes

Title

To analyze the differences in the FiO2 used at different flows

Description

FiO2 will be titrated manually to achieve a predefined SpO2 range (92 - 96%; 88-92% for patients with chronic respiratory disease)

Time Frame

20 minutes

Title

To analyze the differences in patient comfort at different flows, using the visual analogic scale (from 0 to 10)

Description

Comfort score by visual analogic scale. From 0 (worst outcome) to 10 (best outocome).

Time Frame

20 minutes.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Oriol Roca, MD PhD

Phone

+34932746209

oroca@vhebron.net

First Name & Middle Initial & Last Name or Official Title & Degree

Francisco Ramos, MD

Phone

+34932746209

f.ramos@vhebron.net

Facility Information:

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oriol Roca, MD PhD

Phone

+34932746209

oroca@vhebron.net

First Name & Middle Initial & Last Name & Degree

Francisco Ramos, MD

Phone

+34932746209

f.ramos@vhebron.net

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32901374

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.

Results Reference

background

PubMed Identifier

28762180

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.

Results Reference

background

PubMed Identifier

27481760

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.

Results Reference

background

PubMed Identifier

30360753

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.

Results Reference

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

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