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).

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Mar 2022

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12 months study duration

Study Start

First participant enrolled

March 18, 2022

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed

2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2022

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed

Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

April 5, 2022

Last Update Submit

May 27, 2022

Conditions

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

Keywords

High-Flow Nasal CannulaOxygen therapyElectrical Impedance TomographyLung injuryAcute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

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 Outcomes (6)

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).
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).
20 minutes
To analyze the differences in SpO2 at different flows
20 minutes
To analyze the differences in respiratory rate at different flows
20 minutes
To analyze the differences in the FiO2 used at different flows
20 minutes
+1 more secondary outcomes

Study Arms (3)

30 L/min

ACTIVE COMPARATOR

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

Device: High Flow Nasal Cannula at 30L/min

45 L/min

EXPERIMENTAL

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

Device: High Flow Nasal Cannula at 45L/min

60 L/min

EXPERIMENTAL

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

Device: High Flow Nasal Cannula at 60L/min

Interventions

High Flow Nasal Cannula at 30L/minDEVICE

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

30 L/min

High Flow Nasal Cannula at 45L/minDEVICE

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

45 L/min

High Flow Nasal Cannula at 60L/minDEVICE

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

60 L/min

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult patient admitted to the ICU requiring NHF due to AHRF that will be defined as an SpO2/FIO2 ratio \<315

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Hospital Universitari Vall d'Hebron Research Institutelead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Related Publications (4)

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.
PMID: 32901374BACKGROUND
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.
PMID: 28762180BACKGROUND
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.
PMID: 27481760BACKGROUND
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.
PMID: 30360753BACKGROUND

MeSH Terms

Conditions

Respiratory InsufficiencyLung Injury

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesLung DiseasesThoracic InjuriesWounds and Injuries

Central Study Contacts

Oriol Roca, MD PhD

CONTACT

+34932746209 oroca@vhebron.net

Francisco Ramos, MD

CONTACT

+34932746209 f.ramos@vhebron.net

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: SUPPORTIVE CARE
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 5, 2022

First Posted

June 2, 2022

Study Start

March 18, 2022

Primary Completion

November 5, 2022

Study Completion

February 28, 2023

Last Updated

June 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing: Will not share

Locations

ES(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

30 L/min

45 L/min

60 L/min

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations