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

Respiratory Failure Clinical Trial

— iFLOW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05401474
• Other study ID #: PR(AG)21/2022
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2022
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Oriol Roca, MD PhD
• Phone: +34932746209
• Email: oroca[@]vhebron.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: February 28, 2023
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. Review. — View 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. — View 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. Review. — View Citation

Roca O, Messika J, Caralt B, García-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	To analyze the differences in SpO2 at different flows	SpO2 by pulseoxymetry	20 minutes
Secondary	To analyze the differences in respiratory rate at different flows	Breaths/minute	20 minutes
Secondary	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
Secondary	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.