Clinical trial NCT04711759: Physiologic Effects of High-flow Nasal Cannula Versus Standard Oxygen Therapy Postextubation in Critically Ill Patients
Official title: Postextubation High-flow Nasal Cannula Versus Standard Oxygen Therapy in Critically Ill Patients: a Physiologic Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Weaning
Keywords: High flow nasal cannula
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
First posted: 2021-01-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pressure time-product (PTP) per minute (cmH2O x s/min)
timeFrame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
measure: Delta end-expiratory lung index (EELI)
timeFrame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
measure: Brain natriuretic peptide (BNP) plasma levels
timeFrame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Secondary outcomes:
measure: Pressure time-product per breath (cmH2O x s)
timeFrame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
measure: Peak electric activity of the diaphragm (EAdi)
timeFrame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
measure: Neuroventilatory efficiency
timeFrame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
measure: Neuromechanical efficiency
timeFrame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
measure: Global inhomogeneity index
timeFrame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
measure: PaO2 / FiO2
timeFrame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico UC Christus
state: Region Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Alejandro Bruhn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
citation: Fernandez R, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Masclans JR, Lesmes A, Panadero L, Hernandez G. High-flow nasal cannula to prevent postextubation respiratory failure in high-risk non-hypercapnic patients: a randomized multicenter trial. Ann Intensive Care. 2017 Dec;7(1):47. doi: 10.1186/s13613-017-0270-9. Epub 2017 May 2.
citation: Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.