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

NCT04711759 | Completed

• 2 other identifiers: 1808140011191709
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Weaning

Keywords

High flow nasal cannula

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Brain natriuretic peptide (BNP) plasma levels

  60 minutes after starting high flow nasal cannula or standard oxygen therapy

Secondary Outcomes (6)

• Pressure time-product per breath (cmH2O x s)

  60 minutes after starting high flow nasal cannula or standard oxygen therapy

• Peak electric activity of the diaphragm (EAdi)

  60 minutes after starting high flow nasal cannula or standard oxygen therapy

• Neuroventilatory efficiency

  60 minutes after starting high flow nasal cannula or standard oxygen therapy

• Neuromechanical efficiency

  60 minutes after starting high flow nasal cannula or standard oxygen therapy

• Global inhomogeneity index

  60 minutes after starting high flow nasal cannula or standard oxygen therapy

Study Arms (2)

Sequence A: High flow nasal cannula - Standard oxygen therapy

EXPERIMENTAL

Once participants are extubated they will receive one hour of high flow nasal cannula followed by one hour of standard oxygen therapy.

Device: High flow nasal cannula; Device: Standard oxygen therapy

Sequence B: Standard oxygen therapy - High flow nasal cannula

EXPERIMENTAL

Once participants are extubated they will receive one hour of standard oxygen therapy followed by one hour of high flow nasal cannula.

Device: High flow nasal cannula; Device: Standard oxygen therapy

Interventions

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: High flow nasal cannula - Standard oxygen therapy; Sequence B: Standard oxygen therapy - High flow nasal cannula

Standard oxygen therapy DEVICE

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.

Sequence A: High flow nasal cannula - Standard oxygen therapy; Sequence B: Standard oxygen therapy - High flow nasal cannula

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
• 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

You may not qualify if:

• 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

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)

• 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.

  PMID: 26975498 BACKGROUND

• 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.

  PMID: 28466461 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

• Basoalto R, Damiani LF, Jalil Y, Bachmann MC, Oviedo V, Alegria L, Valenzuela ED, Rovegno M, Ruiz-Rudolph P, Cornejo R, Retamal J, Bugedo G, Thille AW, Bruhn A. Physiological effects of high-flow nasal cannula oxygen therapy after extubation: a randomized crossover study. Ann Intensive Care. 2023 Oct 18;13(1):104. doi: 10.1186/s13613-023-01203-z.

  PMID: 37851284 DERIVED

Study Officials

• Alejandro Bruhn, MD, PhD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: January 27, 2021
• Primary Completion: November 17, 2022
• Study Completion: December 17, 2022
• Last Updated: January 13, 2025

Record last verified: 2021-01

Locations

CL (1)