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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04711759
Enrollment
26
Registered
2021-01-15
Start date
2021-01-27
Completion date
2022-12-17
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Weaning

Keywords

High flow nasal cannula

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.

Interventions

DEVICEHigh 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.

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.

Sponsors

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
CollaboratorOTHER_GOV
Pontificia Universidad Catolica de Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Analysis of work of breathing and of data derived from Electric impedance tomography will be performed blind to arm assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Mechanical ventilation (MV) through an orotracheal tube for at least 48 hours * PaO2 /FiO2 ratio ≤ 300 mmHg * Potential for weaning as determined in routine daily screening (precipitating cause leading to MV in resolution, adequate oxygenation (PaO2/FiO2 ≥150 mmHg with FiO2 ≤0.4 and PEEP ≤8 cm H2O), arterial pH \>7.25, hemodynamic stability (no vasopressors or Noradrenaline ≤0.1 mcg/kg/min), temperature \<38°C, presence of inspiratory effort and appropriate spontaneous cough, and the patient is not receiving sedatives and is awake and able to follow simple commands) * Decision to perform a spontaneous breathing trial by the attending physician

Exclusion criteria

* Patients ventilated for decompensated chronic obstructive pulmonary disease * Contraindications to HFNC, which include abnormalities or surgery of the face, nose, or airway that preclude an appropriate-fitting nasal cannula. * Contraindications for esophageal balloon catheter insertion (eg. severe coagulopathy, esophageal varices, and history of esophageal or gastric surgery) * Contraindication for use of electric impedance tomography (eg. Pacemaker) * Presence of tracheostomy * Refusal to participate by the attending physician * Do not resuscitate order

Design outcomes

Primary

MeasureTime frameDescription
Pressure time-product (PTP) per minute (cmH2O x s/min)60 minutes after starting high flow nasal cannula or standard oxygen therapyPTPmin will be assessed through an esophageal Neurovent catheter.
Delta end-expiratory lung index (EELI)60 minutes after starting high flow nasal cannula or standard oxygen therapyDelta EELI will be obtained from electric impedance tomography (EIT) and measured relative to the tidal volume.
Brain natriuretic peptide (BNP) plasma levels60 minutes after starting high flow nasal cannula or standard oxygen therapy

Secondary

MeasureTime frameDescription
Neuromechanical efficiency60 minutes after starting high flow nasal cannula or standard oxygen therapyRatio of the (Paw-PEEP) divided by EAdi during inspiratory occlusion (cmH2O / uV)
Pressure time-product per breath (cmH2O x s)60 minutes after starting high flow nasal cannula or standard oxygen therapyPTP will be assessed through an esophageal Neurovent catheter.
PaO2 / FiO260 minutes after starting high flow nasal cannula or standard oxygen therapyParameter of oxygen exchange calculated as the ratio of PaO2 / FiO2
Global inhomogeneity index60 minutes after starting high flow nasal cannula or standard oxygen therapyindex 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
Peak electric activity of the diaphragm (EAdi)60 minutes after starting high flow nasal cannula or standard oxygen therapyEAdi will be measured in uV through a Neurovent catheter connected to a Servo-i ventilator
Neuroventilatory efficiency60 minutes after starting high flow nasal cannula or standard oxygen therapyVt / EAdi (ml / uV)

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026