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

NCT05012696 | Completed

• 1 other identifier: 210301011
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Weaning from Mechanical Ventilation

Keywords

Noninvasive ventilation; High-flow nasal cannula

Outcome Measures

Primary Outcomes (3)

• 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

• Esophageal pressure swings (ΔPes)

  Esophageal pressure swings (ΔPes) defined as the absolute differences between end-expiratory and end-inspiratory Pes

  60 minutes after starting Non-invasive ventilation or high flow nasal cannula

• 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 Outcomes (7)

• Pressure time-product per breath

  60 minutes after starting Non-invasive ventilation or high flow nasal cannula

• Peak electric activity of the diaphragm (EAdi)

  60 minutes after starting Non-invasive ventilation or high flow nasal cannula

• Neuroventilatory efficiency

  60 minutes after starting Non-invasive ventilation or high flow nasal cannula

• Diaphragmatic neuromuscular coupling

  60 minutes after starting Non-invasive ventilation or high flow nasal cannula

• Global inhomogeneity index

  60 minutes after starting Non-invasive ventilation or high flow nasal cannula ]

Study Arms (2)

Sequence A: Non-invasive ventilation - High flow nasal cannula

EXPERIMENTAL

Once participants are extubated they will receive one hour of Non-invasive ventilation followed by one hour of high-flow nasal cannula.

Device: Non-invasive ventilation (NIV); Device: High-flow nasal cannula

Sequence B: High flow nasal cannula - Non-invasive ventilation

EXPERIMENTAL

Once participants are extubated they will receive one hour of high flow nasal cannula followed by one hour of Non-invasive ventilation

Device: Non-invasive ventilation (NIV); Device: High-flow nasal cannula

Interventions

Non-invasive ventilation (NIV) DEVICE

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.

Sequence A: Non-invasive ventilation - High flow nasal cannula; Sequence B: High flow nasal cannula - Non-invasive ventilation

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.

Sequence A: Non-invasive ventilation - High flow nasal cannula; Sequence B: High flow nasal cannula - Non-invasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanical ventilation (MV) through an orotracheal tube for at least 48 hours
• PaO2 /FiO2 ratio ≤ 300 mmHg (during the MV period)
• 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
• 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.

You may not qualify if:

• Contraindications to NIV or HFNC, which include abnormalities, trauma or surgery of the face or nose.
• 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)
• Tracheostomy
• Refusal to participate by the attending physician
• Do not resuscitate order

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator

Study Sites (1)

Hospital Clínico UC Christus

Santiago, Santiago Metropolitan, 114D, Chile

Location

Related Publications (4)

• 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.

  PMID: 28860265 BACKGROUND

• 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.

  PMID: 31577036 BACKGROUND

• 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.

  PMID: 27706464 BACKGROUND

• 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.

  PMID: 27997805 BACKGROUND

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysis of work of breathing and of data derived from Electric impedance tomography will be performed blind to arm assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 19, 2021
• Study Start: September 16, 2021
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)