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| ID | Type | Description | Link |
|---|---|---|---|
| 1191709 | Other Grant/Funding Number | Fondecyt |
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| Name | Class |
|---|---|
| Fondo Nacional de Desarrollo CientÃfico y Tecnológico, Chile | OTHER_GOV |
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High-flow nasal cannula (HFNC) is a rather novel system to provide oxygen therapy, which provides flows up to 60 liters/minute (LPM) of heated and humidified gas through nasal prongs. HFNC is increasingly being used in patients with acute respiratory failure. In healthy volunteers and in patients with acute respiratory failure it has been shown to induce several effects beyond those expected for a standard oxygen therapy, such as increased carbon dioxide (CO2) clearance and positive airway pressure.
One of the potential indications for HFNC is to facilitate weaning from mechanical ventilation and extubation. As weaning failure is one of the most complex challenges in mechanically ventilated patients, the use of HFNC after extubation, in order to prevent reintubation, has been evaluated in some clinical trials, with promising results. However, the role of HFNC postextubation is still controversial, and information regarding its effects on the pathophysiologic mechanisms of weaning failure is lacking.
The goal of this proposal is to compare the acute physiologic effects of postextubation HFNC versus standard oxygen therapy, in critically ill patients, on relevant mechanisms related to weaning failure: work of breathing, lung function, systemic hemodynamics.
This will be a randomized crossover study which will include critically ill mechanically ventilated patients, who fulfill criteria indicating they may be ready for weaning from mechanical ventilation, and in whom a spontaneous breathing trial (SBT) is planned to determine if they should be extubated. After checking eligibility and obtaining informed consent, patients will be monitored with an esophageal catheter (esophageal / gastric pressures to determine work of breathing, and electric activity of diaphragm to determine neuromechanical coupling), and a noninvasive ventilation monitor (electric impedance tomography to assess global and regional ventilation). Work of breathing, lung function, and systemic hemodynamics will be assessed during the SBT. Inclusion in the study will be confirmed only if they pass the SBT and are extubated. During the first 2 hours after extubation patients will undergo one hour of HFNC and one hour of standard oxygen therapy, with the crossover sequence being randomized previously at the time of inclusion, and with assessments repeated at the end of each treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A: High flow nasal cannula - Standard oxygen therapy | Experimental | Once participants are extubated they will receive one hour of high flow nasal cannula followed by one hour of standard oxygen therapy. |
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| Sequence B: Standard oxygen therapy - High flow nasal cannula | Experimental | Once participants are extubated they will receive one hour of standard oxygen therapy followed by one hour of high flow nasal cannula. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow nasal cannula | Device | High flow nasal cannula will be provided through a commercial device (AIRVO2 + Optiflow nasal cannula, Fisher & Paykel), at 50 LPM and at the same FiO2 applied during the spontaneous breathing trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure time-product (PTP) per minute (cmH2O x s/min) | PTPmin will be assessed through an esophageal Neurovent catheter. | 60 minutes after starting high flow nasal cannula or standard oxygen therapy |
| Delta end-expiratory lung index (EELI) | Delta EELI will be obtained from electric impedance tomography (EIT) and measured relative to the tidal volume. | 60 minutes after starting high flow nasal cannula or standard oxygen therapy |
| Brain natriuretic peptide (BNP) plasma levels | 60 minutes after starting high flow nasal cannula or standard oxygen therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure time-product per breath (cmH2O x s) | PTP will be assessed through an esophageal Neurovent catheter. | 60 minutes after starting high flow nasal cannula or standard oxygen therapy |
| Peak electric activity of the diaphragm (EAdi) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro Bruhn, MD, PhD | Pontificia Universidad Catolica de Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico UC Christus | Santiago | Santiago Metropolitan | 114D | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26975498 | Result | Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711. | |
| 28466461 |
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Analysis of work of breathing and of data derived from Electric impedance tomography will be performed blind to arm assignment
| Standard oxygen therapy | Device | Standard oxygen therapy will be provided through a Venturi mask and O2 flow will be adjusted to keep the same FiO2 applied during the spontaneous breathing trial. |
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EAdi will be measured in uV through a Neurovent catheter connected to a Servo-i ventilator
| 60 minutes after starting high flow nasal cannula or standard oxygen therapy |
| Neuroventilatory efficiency | Vt / EAdi (ml / uV) | 60 minutes after starting high flow nasal cannula or standard oxygen therapy |
| Neuromechanical efficiency | Ratio of the (Paw-PEEP) divided by EAdi during inspiratory occlusion (cmH2O / uV) | 60 minutes after starting high flow nasal cannula or standard oxygen therapy |
| Global inhomogeneity index | index derived from EIT and calculated from the sum of the impedance changes of each pixel with respect to its median (in absolute values), divided by the sum of the impedance values of each pixel | 60 minutes after starting high flow nasal cannula or standard oxygen therapy |
| PaO2 / FiO2 | Parameter of oxygen exchange calculated as the ratio of PaO2 / FiO2 | 60 minutes after starting high flow nasal cannula or standard oxygen therapy |
| Fernandez R, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Masclans JR, Lesmes A, Panadero L, Hernandez G. High-flow nasal cannula to prevent postextubation respiratory failure in high-risk non-hypercapnic patients: a randomized multicenter trial. Ann Intensive Care. 2017 Dec;7(1):47. doi: 10.1186/s13613-017-0270-9. Epub 2017 May 2. |
| 27997805 | Result | Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC. |
| 37851284 | Derived | Basoalto R, Damiani LF, Jalil Y, Bachmann MC, Oviedo V, Alegria L, Valenzuela ED, Rovegno M, Ruiz-Rudolph P, Cornejo R, Retamal J, Bugedo G, Thille AW, Bruhn A. Physiological effects of high-flow nasal cannula oxygen therapy after extubation: a randomized crossover study. Ann Intensive Care. 2023 Oct 18;13(1):104. doi: 10.1186/s13613-023-01203-z. |