Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT04711759
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2021-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiologic Effects of High-flow Nasal Cannula Versus Standard Oxygen Therapy Postextubation in Critically Ill Patients
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Study Overview
Official Title:
Postextubation High-flow Nasal Cannula Versus Standard Oxygen Therapy in Critically Ill Patients: a Physiologic Randomized Crossover Study
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1191709 | OTHER_GRANT | Fondecyt | View |