Weaning From Mechanical VentilationNCT05012696
Physiological Effects of Non-invasive Mechanical Ventilation Versus High-flow Nasal Cannula in Critically Ill Patients at High Risk of Extubation Failure
A study testing Non-invasive ventilation (NIV) and High-flow nasal cannula in people with Weaning From Mechanical Ventilation, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning From Mechanical Ventilation
- What is being tested?
- Non-invasive ventilation (NIV) and High-flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChile
- Study dates
- 16 Sep 2021to 24 Apr 2024
- 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 (during the MV period)
- Potential for weaning
- Precipitating cause leading to MV in resolution
- PaO2 /FiO2 ratio ≥ 150 mmHg
- PEEP ≤ 8 cmH2O
Show all 13Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Non-invasive ventilation (NIV), High-flow nasal cannula
- Keywords
- Noninvasive ventilation, High-flow nasal cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Non-invasive ventilation (NIV); Device: High-flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure time-product (PTP) per minute
Pressure time-product (PTP) per minute (cmH2O x s/min)
Measured: 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
Measured: 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
Measured: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Secondary outcomes (7)
Pressure time-product per breath
Pressure time-product per breath (cmH2O x s). PTP will be assessed through an esophageal Neurovent catheter.
Measured: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Peak electric activity of the diaphragm (EAdi)
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 Non-invasive ventilation or high flow nasal cannula
Neuroventilatory efficiency
Neuroventilatory efficiency is a parameter derived from the EAdi signal and the ventilation
Measured: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Diaphragmatic neuromuscular coupling
Diaphragmatic neuromuscular coupling Pdi/EAdi
Measured: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
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 Non-invasive ventilation or high flow nasal cannula ]
PaO2 / FiO2 ratio
Parameter of oxygen exchange calculated as the ratio of PaO2 / FiO2
Measured: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
PaCO2
Arterial partial pressure of CO2 (PaCO2) Parameter of alveolar ventilation
Measured: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start16 Sep 2021
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
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 Weaning From Mechanical VentilationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012696
- Sponsor's protocol ID
- 210301011
- Status last verified
- Dec 2024
- First submitted
- 12 Aug 2021
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28860265Thille 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.
PubMed 31577036Hernandez 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.
PubMed 27706464Mauri 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 27997805
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05012696
- Acronym / sponsor ID
- 210301011
- Conditions
- Weaning From Mechanical Ventilation
- Keywords
- Noninvasive ventilation, High-flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 19 Aug 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Non-invasive ventilation - High flow nasal cannula | Experimental | Device: Non-invasive ventilation (NIV), Device: High-flow nasal cannulaOnce participants are extubated they will receive one hour of Non-invasive ventilation followed by one hour of high-flow nasal cannula. |
| Sequence B: High flow nasal cannula - Non-invasive ventilation | Experimental | Device: Non-invasive ventilation (NIV), Device: High-flow nasal cannulaOnce participants are extubated they will receive one hour of high flow nasal cannula followed by one hour of Non-invasive ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Mechanical ventilation (MV) through an orotracheal tube for at least 48 hours
- PaO2 /FiO2 ratio ≤ 300 mmHg (during the MV period)
- Potential for weaning
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Non-invasive ventilation (NIV)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. | Device | Sequence A: Non-invasive ventilation - High flow nasal cannula, Sequence B: High flow nasal cannula - Non-invasive ventilation |
| 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: Non-invasive ventilation - High flow nasal cannula, Sequence B: High flow nasal cannula - Non-invasive ventilation |
Primary outcome
Pressure time-product (PTP) per minute
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Pressure time-product (PTP) per minute (cmH2O x s/min)
Esophageal pressure swings (ΔPes)
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Esophageal pressure swings (ΔPes) defined as the absolute differences between end-expiratory and end-inspiratory Pes
End-expiratory lung impedance (EELI)
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
End-expiratory lung impedance (EELI)assessed with Electric impedance tomography
7 secondary outcomes
Pressure time-product per breath
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Peak electric activity of the diaphragm (EAdi)
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Neuroventilatory efficiency
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Diaphragmatic neuromuscular coupling
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
Global inhomogeneity index
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula ]
PaO2 / FiO2 ratio
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
PaCO2
Time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula
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 30 Dec 2024.
- Results publication: PubMed 28860265Rochwerg 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.
- Results publication: PubMed 31577036Thille 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.
- Results publication: PubMed 27706464Hernandez 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.
- 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ventilation (NIV) and High-flow nasal cannula in people with Weaning From Mechanical Ventilation, 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 13 inclusion and 6 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 30 Dec 2024. 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 (time frame: 60 minutes after starting Non-invasive ventilation or high flow nasal cannula). 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 NCT05012696, 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 30 Dec 2024.