Hospital Clínico UC Christus
Santiago, Santiago Metropolitan, 114D, Chile
NCT Number: NCT05012696
Weaning is one of the most complex challenges in mechanically ventilated patients. Increased work of breathing after extubation would play a central role in weaning failure. Currently, non-invasive ventilation (NIV) is recommended to prevent weaning failure in high-risk patients. On the other hand, high-flow nasal cannula (HFNC), which is a novel system capable of administering gas mixtures (air and oxygen) with a flow of up to 60 liters/min, has been used to prevent weaning failure in this kind of patients. The use of NIV and HFNC after extubation has been evaluated in some clinical studies. However, the evidence is controversial, and the information regarding the physiological effects that each therapy induces in recently extubated patients at high risk of weaning failure is lacking.
The goal of this proposal is to compare the acute physiological effects of postextubation NIV versus HFNC in critically ill patients at high risk of weaning failure on relevant mechanisms related to weaning failure: Work of breathing, lung function, ventilation distribution, systemic hemodynamics.
This will be a randomized crossover study that 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 NIV and one hour of HFNC, 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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Santiago, Santiago Metropolitan, 114D, Chile
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-invasive ventilation will be provided through a mechanical ventilator (Carina, Dräger) through a facial interface (Fitlife Respironics, Philips). A PEEP level between 5 and 10 cmH2O, minimal pressure-support level of 5 cm H2O targeting a tidal volume around 6 to 8 ml/kg and at the same FiO2 applied during the spontaneous breathing trial.
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.
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Pressure time-product (PTP) per minute (cmH2O x s/min)
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Esophageal pressure swings (ΔPes) defined as the absolute differences between end-expiratory and end-inspiratory Pes
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
End-expiratory lung impedance (EELI)assessed with Electric impedance tomography
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Pressure time-product per breath (cmH2O x s). PTP will be assessed through an esophageal Neurovent catheter.
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Peak electric activity of the diaphragm (EAdi) EAdi will be measured in uV through a Neurovent catheter connected to a Servo-i ventilator
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Neuroventilatory efficiency is a parameter derived from the EAdi signal and the ventilation
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Diaphragmatic neuromuscular coupling Pdi/EAdi
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula ]
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
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Parameter of oxygen exchange calculated as the ratio of PaO2 / FiO2
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Arterial partial pressure of CO2 (PaCO2) Parameter of alveolar ventilation
Pontificia Universidad Catolica de Chile
Other
Postextubation Non-invasive Ventilation Versus High-flow Nasal Cannula in Critically Ill Patients at High Risk of Weaning Failure: a Physiologic Randomized Crossover Study
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