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Completed

NCT Number: NCT04711759

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico UC Christus

Santiago, Santiago Metropolitan, 114D, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Flow Nasal Cannula

Device

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

Device

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.

Primary outcomes

  1. Pressure time-product (PTP) per minute (cmH2O x s/min)

    Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy

    PTPmin will be assessed through an esophageal Neurovent catheter.

  2. Delta end-expiratory lung index (EELI)

    Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy

    Delta EELI will be obtained from electric impedance tomography (EIT) and measured relative to the tidal volume.

  3. Brain natriuretic peptide (BNP) plasma levels

    Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy

Secondary outcomes

  1. Pressure time-product per breath (cmH2O x s)

    Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy

    PTP will be assessed through an esophageal Neurovent catheter.

  2. Peak electric activity of the diaphragm (EAdi)

    Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy

    EAdi will be measured in uV through a Neurovent catheter connected to a Servo-i ventilator

  3. Neuroventilatory efficiency

    Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy

    Vt / EAdi (ml / uV)

  4. Neuromechanical efficiency

    Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy

    Ratio of the (Paw-PEEP) divided by EAdi during inspiratory occlusion (cmH2O / uV)

  5. Global inhomogeneity index

    Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy

    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

  6. PaO2 / FiO2

    Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy

    Parameter of oxygen exchange calculated as the ratio of PaO2 / FiO2

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Collaborators

  • Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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