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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 L/min | Active Comparator | HFNC at 30L/min. FiO2 adjusted to reach SpO2 95% |
|
| 45 L/min | Experimental | HFNC at 45L/min. FiO2 adjusted to reach SpO2 95% |
|
| 60 L/min | Experimental | HFNC at 60L/min. FiO2 adjusted to reach SpO2 95% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Nasal Cannula at 30L/min | Device | Flow will be set at 30L/min, FiO2 will be adjusted manually to maintain SpO2within the target range |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oriol Roca, MD PhD | Contact | +34932746209 | oroca@vhebron.net | |
| Francisco Ramos, MD | Contact | +34932746209 | f.ramos@vhebron.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32901374 | Background | 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. | |
| 28762180 | Background |
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| High Flow Nasal Cannula at 45L/min | Device | 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 | Device | Flow will be set at 60L/min, FiO2 will be adjusted manually to maintain SpO2within the target range |
|
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. |
| 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. |
| 27481760 | Background | 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. |
| 30360753 | Background | 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. |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D055370 | Lung Injury |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
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