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

Primary Purpose

Ventilator Weaning

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
High flow nasal cannula
Standard oxygen therapy
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator Weaning focused on measuring High flow nasal cannula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clínico UC Christus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence A: High flow nasal cannula - Standard oxygen therapy

Sequence B: Standard oxygen therapy - High flow nasal cannula

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pressure time-product (PTP) per minute (cmH2O x s/min)
PTPmin will be assessed through an esophageal Neurovent catheter.
Delta end-expiratory lung index (EELI)
Delta EELI will be obtained from electric impedance tomography (EIT) and measured relative to the tidal volume.
Brain natriuretic peptide (BNP) plasma levels

Secondary Outcome Measures

Pressure time-product per breath (cmH2O x s)
PTP will be assessed through an esophageal Neurovent catheter.
Peak electric activity of the diaphragm (EAdi)
EAdi will be measured in uV through a Neurovent catheter connected to a Servo-i ventilator
Neuroventilatory efficiency
Vt / EAdi (ml / uV)
Neuromechanical efficiency
Ratio of the (Paw-PEEP) divided by EAdi during inspiratory occlusion (cmH2O / uV)
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
PaO2 / FiO2
Parameter of oxygen exchange calculated as the ratio of PaO2 / FiO2

Full Information

First Posted
January 13, 2021
Last Updated
April 3, 2023
Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
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1. Study Identification

Unique Protocol Identification Number
NCT04711759
Brief Title
Physiologic Effects of High-flow Nasal Cannula Versus Standard Oxygen Therapy Postextubation in Critically Ill Patients
Official Title
Postextubation High-flow Nasal Cannula Versus Standard Oxygen Therapy in Critically Ill Patients: a Physiologic Randomized Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
December 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Weaning
Keywords
High flow nasal cannula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Masking Description
Analysis of work of breathing and of data derived from Electric impedance tomography will be performed blind to arm assignment
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence A: High flow nasal cannula - Standard oxygen therapy
Arm Type
Experimental
Arm Description
Once participants are extubated they will receive one hour of high flow nasal cannula followed by one hour of standard oxygen therapy.
Arm Title
Sequence B: Standard oxygen therapy - High flow nasal cannula
Arm Type
Experimental
Arm Description
Once participants are extubated they will receive one hour of standard oxygen therapy followed by one hour of high flow nasal cannula.
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard oxygen therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pressure time-product (PTP) per minute (cmH2O x s/min)
Description
PTPmin will be assessed through an esophageal Neurovent catheter.
Time Frame
60 minutes after starting high flow nasal cannula or standard oxygen therapy
Title
Delta end-expiratory lung index (EELI)
Description
Delta EELI will be obtained from electric impedance tomography (EIT) and measured relative to the tidal volume.
Time Frame
60 minutes after starting high flow nasal cannula or standard oxygen therapy
Title
Brain natriuretic peptide (BNP) plasma levels
Time Frame
60 minutes after starting high flow nasal cannula or standard oxygen therapy
Secondary Outcome Measure Information:
Title
Pressure time-product per breath (cmH2O x s)
Description
PTP will be assessed through an esophageal Neurovent catheter.
Time Frame
60 minutes after starting high flow nasal cannula or standard oxygen therapy
Title
Peak electric activity of the diaphragm (EAdi)
Description
EAdi will be measured in uV through a Neurovent catheter connected to a Servo-i ventilator
Time Frame
60 minutes after starting high flow nasal cannula or standard oxygen therapy
Title
Neuroventilatory efficiency
Description
Vt / EAdi (ml / uV)
Time Frame
60 minutes after starting high flow nasal cannula or standard oxygen therapy
Title
Neuromechanical efficiency
Description
Ratio of the (Paw-PEEP) divided by EAdi during inspiratory occlusion (cmH2O / uV)
Time Frame
60 minutes after starting high flow nasal cannula or standard oxygen therapy
Title
Global inhomogeneity index
Description
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
Time Frame
60 minutes after starting high flow nasal cannula or standard oxygen therapy
Title
PaO2 / FiO2
Description
Parameter of oxygen exchange calculated as the ratio of PaO2 / FiO2
Time Frame
60 minutes after starting high flow nasal cannula or standard oxygen therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Bruhn, MD, PhD
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico UC Christus
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
114D
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
26975498
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 Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
Results Reference
result
PubMed Identifier
28466461
Citation
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.
Results Reference
result
PubMed Identifier
27997805
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.
Results Reference
result

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

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