NCT05012696

Physiological Effects of Non-invasive Mechanical Ventilation Versus High-flow Nasal Cannula in Critically Ill Patients at High Risk of Extubation Failure

Postextubation Non-invasive Ventilation Versus High-flow Nasal Cannula in Critically Ill Patients at High Risk of Weaning Failure: a Physiologic Randomized Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Weaning From Mechanical Ventilation

Interventions

Type	Name	Description
DEVICE	Non-invasive ventilation (NIV)	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.
DEVICE	High-flow nasal cannula	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.

Timeline

• Start date: 2021-09-16
• Primary completion: 2024-04-24
• Completion: 2024-04-24
• First posted: 2021-08-19
• Last updated: 2024-12-30

Locations

1 site across 1 country: Chile