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

Ventilator Weaning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711759
• Other study ID #: 180814001
• Secondary ID: 1191709
• Status: Completed
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: December 17, 2022

Study information

• Verified date: January 2021
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 17, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Ventilator Weaning

Intervention

Device:
• High 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
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.

Locations

Country	Name	City	State
Chile	Hospital Clínico UC Christus	Santiago	Region Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (3)

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 Int — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure time-product (PTP) per minute (cmH2O x s/min)	PTPmin will be assessed through an esophageal Neurovent catheter.	60 minutes after starting high flow nasal cannula or standard oxygen therapy
Primary	Delta end-expiratory lung index (EELI)	Delta EELI will be obtained from electric impedance tomography (EIT) and measured relative to the tidal volume.	60 minutes after starting high flow nasal cannula or standard oxygen therapy
Primary	Brain natriuretic peptide (BNP) plasma levels		60 minutes after starting high flow nasal cannula or standard oxygen therapy
Secondary	Pressure time-product per breath (cmH2O x s)	PTP will be assessed through an esophageal Neurovent catheter.	60 minutes after starting high flow nasal cannula or standard oxygen therapy
Secondary	Peak electric activity of the diaphragm (EAdi)	EAdi will be measured in uV through a Neurovent catheter connected to a Servo-i ventilator	60 minutes after starting high flow nasal cannula or standard oxygen therapy
Secondary	Neuroventilatory efficiency	Vt / EAdi (ml / uV)	60 minutes after starting high flow nasal cannula or standard oxygen therapy
Secondary	Neuromechanical efficiency	Ratio of the (Paw-PEEP) divided by EAdi during inspiratory occlusion (cmH2O / uV)	60 minutes after starting high flow nasal cannula or standard oxygen therapy
Secondary	Global inhomogeneity index	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	60 minutes after starting high flow nasal cannula or standard oxygen therapy
Secondary	PaO2 / FiO2	Parameter of oxygen exchange calculated as the ratio of PaO2 / FiO2	60 minutes after starting high flow nasal cannula or standard oxygen therapy