Clinical trial NCT05012696: Physiological Effects of Non-invasive Mechanical Ventilation Versus High-flow Nasal Cannula in Critically Ill Patients At High Risk of Extubation Failure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weaning from Mechanical Ventilation
Keywords: Noninvasive ventilation
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: 2021-08-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pressure time-product (PTP) per minute
timeFrame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
measure: Esophageal pressure swings (ΔPes)
timeFrame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
measure: End-expiratory lung impedance (EELI)
timeFrame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Secondary outcomes:
measure: Pressure time-product per breath
timeFrame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
measure: Peak electric activity of the diaphragm (EAdi)
timeFrame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
measure: Neuroventilatory efficiency
timeFrame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
measure: Diaphragmatic neuromuscular coupling
timeFrame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
measure: Global inhomogeneity index
timeFrame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula ]
measure: PaO2 / FiO2 ratio
timeFrame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
measure: PaCO2
timeFrame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico UC Christus
state: Region Metropolitana
Study officials:
References:
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 clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
citation: Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901.
citation: Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
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.