Clinical Trials Directory

Trials / Completed

CompletedNCT04711759

Physiologic Effects of High-flow Nasal Cannula Versus Standard Oxygen Therapy Postextubation in Critically Ill Patients

Postextubation High-flow Nasal Cannula Versus Standard Oxygen Therapy in Critically Ill Patients: a Physiologic Randomized Crossover Study

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

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.

Conditions

Interventions

TypeNameDescription
DEVICEHigh flow nasal cannulaHigh 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.
DEVICEStandard oxygen therapyStandard 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.

Timeline

Start date
2021-01-27
Primary completion
2022-11-17
Completion
2022-12-17
First posted
2021-01-15
Last updated
2025-01-13

Locations

1 site across 1 country: Chile

Source: ClinicalTrials.gov record NCT04711759. Inclusion in this directory is not an endorsement.