Ventilator WeaningNCT04711759
Physiologic Effects of High-flow Nasal Cannula Versus Standard Oxygen Therapy Postextubation in Critically Ill Patients
A study testing High flow nasal cannula and Standard oxygen therapy in people with Ventilator Weaning, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning
- What is being tested?
- High flow nasal cannula and Standard oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChile
- Study dates
- 27 Jan 2021to 17 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postextubation High-flow Nasal Cannula Versus Standard Oxygen Therapy in Critically Ill Patients: a Physiologic Randomized Crossover Study
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.
Read more
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
- Being tested
- High flow nasal cannula, Standard oxygen therapy
- Keywords
- High flow nasal cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannulaDevice
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.
Standard oxygen therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: High flow nasal cannula; Device: Standard oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure time-product (PTP) per minute (cmH2O x s/min)
PTPmin will be assessed through an esophageal Neurovent catheter.
Measured: 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.
Measured: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Brain natriuretic peptide (BNP) plasma levels
Measured: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Secondary outcomes (6)
Pressure time-product per breath (cmH2O x s)
PTP will be assessed through an esophageal Neurovent catheter.
Measured: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Peak electric activity of the diaphragm (EAdi)
EAdi will be measured in uV through a Neurovent catheter connected to a Servo-i ventilator
Measured: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Neuroventilatory efficiency
Vt / EAdi (ml / uV)
Measured: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Neuromechanical efficiency
Ratio of the (Paw-PEEP) divided by EAdi during inspiratory occlusion (cmH2O / uV)
Measured: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
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
Measured: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
PaO2 / FiO2
Parameter of oxygen exchange calculated as the ratio of PaO2 / FiO2
Measured: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start27 Jan 2021
- Primary completion17 Nov 2022
- Study completion17 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Responsible party
- Sponsor
- Investigators
- Alejandro Bruhn, MD, PhD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711759
- Sponsor's protocol ID
- 180814001
- Other IDs
- 1191709
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26975498Fernandez 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.
PubMed 28466461Mauri 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.
PubMed 27997805Basoalto 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.
PubMed 37851284
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postextubation High-flow Nasal Cannula Versus Standard Oxygen Therapy in Critically Ill Patients: a Physiologic Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT04711759
- Acronym / sponsor ID
- 180814001
- Conditions
- Ventilator Weaning
- Keywords
- High flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Dec 2022 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: High flow nasal cannula - Standard oxygen therapy | Experimental | Device: High flow nasal cannula, Device: Standard oxygen therapyOnce participants are extubated they will receive one hour of high flow nasal cannula followed by one hour of standard oxygen therapy. |
| Sequence B: Standard oxygen therapy - High flow nasal cannula | Experimental | Device: High flow nasal cannula, Device: Standard oxygen therapyOnce participants are extubated they will receive one hour of standard oxygen therapy followed by one hour of high flow nasal cannula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal cannulaHigh 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. | Device | Sequence A: High flow nasal cannula - Standard oxygen therapy, Sequence B: Standard oxygen therapy - High flow nasal cannula |
| Standard oxygen therapyStandard 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. | Device | Sequence A: High flow nasal cannula - Standard oxygen therapy, Sequence B: Standard oxygen therapy - High flow nasal cannula |
Primary outcome
Pressure time-product (PTP) per minute (cmH2O x s/min)
Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
PTPmin will be assessed through an esophageal Neurovent catheter.
Delta end-expiratory lung index (EELI)
Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Delta EELI will be obtained from electric impedance tomography (EIT) and measured relative to the tidal volume.
Brain natriuretic peptide (BNP) plasma levels
Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
6 secondary outcomes
Pressure time-product per breath (cmH2O x s)
Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Peak electric activity of the diaphragm (EAdi)
Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Neuroventilatory efficiency
Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Neuromechanical efficiency
Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Global inhomogeneity index
Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
PaO2 / FiO2
Time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Results publication: PubMed 26975498Hernandez 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 publication: PubMed 28466461Fernandez 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 publication: PubMed 27997805Mauri 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.
- Derived from this study: PubMed 37851284Basoalto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Bruhn, MD, PhD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula and Standard oxygen therapy in people with Ventilator Weaning, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure time-product (PTP) per minute (cmH2O x s/min) (time frame: 60 minutes after starting high flow nasal cannula or standard oxygen therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04711759, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.