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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05401474
Other study ID # PR(AG)21/2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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.
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