Physiological Effects of Non-invasive Mechanical Ventilation Versus High-flow Nasal Cannula in Critically Ill Patients at High Risk of Extubation Failure

Weaning From Mechanical Ventilation Clinical Trial

Official title:

Postextubation Non-invasive Ventilation Versus High-flow Nasal Cannula in Critically Ill Patients at High Risk of Weaning Failure: a Physiologic Randomized Crossover Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05012696
• Other study ID #: 210301011
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: September 16, 2023

Study information

• Verified date: September 2021
• Source: Pontificia Universidad Catolica de Chile
• Contact: Roque Basoalto, PT, PhD(c)
• Phone: 5622354564
• Email: roque.basoalto[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Weaning is one of the most complex challenges in mechanically ventilated patients. Increased work of breathing after extubation would play a central role in weaning failure. Currently, non-invasive ventilation (NIV) is recommended to prevent weaning failure in high-risk patients. On the other hand, high-flow nasal cannula (HFNC), which is a novel system capable of administering gas mixtures (air and oxygen) with a flow of up to 60 liters/min, has been used to prevent weaning failure in this kind of patients. The use of NIV and HFNC after extubation has been evaluated in some clinical studies. However, the evidence is controversial, and the information regarding the physiological effects that each therapy induces in recently extubated patients at high risk of weaning failure is lacking.

The goal of this proposal is to compare the acute physiological effects of postextubation NIV versus HFNC in critically ill patients at high risk of weaning failure on relevant mechanisms related to weaning failure: Work of breathing, lung function, ventilation distribution, systemic hemodynamics.

This will be a randomized crossover study that 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 NIV and one hour of HFNC, 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: Recruiting
• Enrollment: 26
• Est. completion date: September 16, 2023
• Est. primary completion date: September 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Mechanical ventilation (MV) through an orotracheal tube for at least 48 hours

2. PaO2 /FiO2 ratio = 300 mmHg (during the MV period)

3. Potential for weaning

• Precipitating cause leading to MV in resolution

• PaO2 /FiO2 ratio = 150 mmHg

• PEEP = 8 cmH2O

• pH > 7,25

• SpO2 = 90% with FiO2 = 0.4; BPM =35

• Hemodynamic stability (noradrenaline = 0.1mcg / kg / min and SBP 90-160; HR <140)

• Temperature <38 ° C

• Presence of inspiratory effort and appropriate spontaneous cough

• Decision to perform a spontaneous breathing trial by the attending physician

4. High risk of weaning failure defined by a history of: (i) Previous failed extubation, (ii) Chronic heart or respiratory failure, or (iii) MV = 7 days.

Exclusion Criteria:

1. Contraindications to NIV or HFNC, which include abnormalities, trauma or surgery of the face or nose.

2. Contraindications for esophageal balloon catheter insertion (eg. severe coagulopathy, esophageal varices, and history of esophageal or gastric surgery)

3. Contraindication for use of electric impedance tomography (eg. Pacemaker)

4. Tracheostomy

5. Refusal to participate by the attending physician

6. Do not resuscitate order

Related Conditions & MeSH terms

• Critical Illness
• Weaning From Mechanical Ventilation

Intervention

Device:
• Non-invasive ventilation (NIV)
Non-invasive ventilation will be provided through a mechanical ventilator (Carina, Dräger) through a facial interface (Fitlife Respironics, Philips). A PEEP level between 5 and 10 cmH2O, minimal pressure-support level of 5 cm H2O targeting a tidal volume around 6 to 8 ml/kg and at the same FiO2 applied during the spontaneous breathing trial.
• 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.

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 (4)

Hernández G, Vaquero C, Colinas L, Cuena R, González P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernández R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in — 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

Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS c — View Citation

Thille AW, Muller G, Gacouin A, Coudroy R, Decavèle M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouzé A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure time-product (PTP) per minute	Pressure time-product (PTP) per minute (cmH2O x s/min)	60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Primary	Esophageal pressure swings (?Pes)	Esophageal pressure swings (?Pes) defined as the absolute differences between end-expiratory and end-inspiratory Pes	60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Primary	End-expiratory lung impedance (EELI)	End-expiratory lung impedance (EELI)assessed with Electric impedance tomography	60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Secondary	Pressure time-product per breath	Pressure time-product per breath (cmH2O x s). PTP will be assessed through an esophageal Neurovent catheter.	60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Secondary	Peak electric activity of the diaphragm (EAdi)	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 Non-invasive ventilation or high flow nasal cannula
Secondary	Neuroventilatory efficiency	Neuroventilatory efficiency is a parameter derived from the EAdi signal and the ventilation	60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Secondary	Diaphragmatic neuromuscular coupling	Diaphragmatic neuromuscular coupling Pdi/EAdi	60 minutes after starting Non-invasive ventilation or high flow nasal cannula
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 Non-invasive ventilation or high flow nasal cannula ]
Secondary	PaO2 / FiO2 ratio	Parameter of oxygen exchange calculated as the ratio of PaO2 / FiO2	60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Secondary	PaCO2	Arterial partial pressure of CO2 (PaCO2) Parameter of alveolar ventilation	60 minutes after starting Non-invasive ventilation or high flow nasal cannula