Acute Respiratory Distress SyndromeNCT04925518
Closed Loop Mechanical Ventilation and ECMO
A study testing Closed Loop Mechanical Ventilation and Conventional Mechanical Ventilation in people with Acute Respiratory Distress Syndrome and Cardiogenic Shock, run by University of Zurich.
Trial summary
Mechanical ventilation and ECMO are both technologies interacting on gas exchange. Nevertheless, besides a consensus paper, no evidence-based guidelines regarding protective lung ventilation on ECMO exist to date. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Cardiogenic Shock
- What is being tested?
- Closed Loop Mechanical Ventilation and Conventional Mechanical Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2016to 23 May 2018
- 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 and ECMO
- Refractory Acute Respiratory Distress Syndrome or Refractory Cardiogenic Shock
Who cannot join
- Contraindications for ECMO
- Contraindications for Closed Loop Ventilation
- Rejection of participation
About this study
Official title: Closed Loop Mechanical Ventilation Coupled to Extracorporeal Membrane Oxygenation Support in Therapy Refractory Acute Respiratory Distress Syndrome and Cardiogenic Shock
Mechanical ventilation and ECMO are both technologies interacting on gas exchange. Nevertheless, besides a consensus paper, no evidence-based guidelines regarding protective lung ventilation on ECMO exist to date. Mechanical Ventilation with Intellivent-ASV, an algorithm driven, closed loop system, provides an opportunity to standardize ventilation on ECMO.
We propose and validate lung protective ventilation with a closed loop ventilation mode in patients with ECMO.
Read the detailed description
In critically ill patients admitted to the intensive care unit due to either acute respiratory failure or circulatory collapse, mechanical ventilation in combination with either extra-corporal lung assist (VV ECMO) or cardiac assist (VA ECMO) is increasingly used. Both mechanical ventilation and ECMO contribute to the control of gas exchange hence need to be adjusted accordingly.
As an assist device like a VV ECMO or a VA ECMO the control the gas exchange needs to be adjusted via sweep gas flow (ventilation), fraction of oxygen in the sweep gas (oxygenation, FsO2) and blood flow over the extracorporeal device. The combination of adaptive ventilation with ECMO is a novel concept allowing the control of oxygenation and ventilation by the adjustment of the ECMO device only.
Adaptive lung ventilation is a category of ventilation modes, which allow the control of oxygenation and ventilation with a closed loop. Using this type of ventilation modes one can control the gas exchange automatically. In terms of CO2-management they use a target minute volume to control end-tidal CO2 and adjust depending on the amount of spontaneously triggered breaths the respiratory rate and the inspiratory pressure support or solely the pressure support. In terms of O2-management according to the peripheral O2 saturation target the PEEP (lung recruitment) and the fraction of inspired oxygen (FiO2) will be set. Both of these controllers depend on an accurate measurement of either end-tidal CO2 and peripheral O2 saturation, respectively.
There exist two recommendations how to ventilate patients with ARDS on an ECMO. First and foremost, the general guidelines of the Extracorporeal Life Support Organization (ELSO) suggest for adults to target a FiO2 of less than 0.3 with a PEEP of 5 to 15 cmH2O and a plateau pressure of less than 25 cm H2O with a respiratory rate of 5 per minute. Whereas Richard et al. in their consensus conference report from 2014 suggest to minimize plateau pressure and PEEP not being specific in terms of numbers. Both guidelines have the goal of keeping the lung at rest concerning patients with ARDS. There are no specific suggestions on ventilation management in patients with heart failure on ECMO. Whether the lung has to be kept open (recruited and less prone to atelectrauma) or kept at rest (less prone to overdistension, either volu- or barotrauma) is at the moment unclear.
Concerning mechanical ventilation settings in patients with ARDS Serpa Neto and colleagues published in 2016 a meta-analysis of nine studies, which included around 550 patients receiving ECMO for refractory hypoxemia. They showed that in these patients driving pressure was associated with in-hospital survival (survivors had a driving pressure of 16.9 cmH2O and non-survivors of 19.4, p 0.004, adjusted HR 1.06 with a 95% CI of 1.03 - 1.10). This is consistent with the study of Amato et al where they showed a reduction of the multivariate relative risk of in-hospital mortality in patients with ARDS - without ECMO - with a driving pressure of less than 15 cmH2O.
The adaptive lung ventilation mode Intellivent-ASV+® has been shown to ventilate normal lungs, lungs with ARDS and COPD within the limits of safe ventilation recommended by the guidelines. Patients on Intellivent-ASV+® had tidal volumes (Vt) ≤ 8 ml/kg/BW, plateau pressure (Pplat) < 30 cmH2O and a driving pressure < 15 cmH2O. Compared to conventional ventilation, patients on Intellivent-ASV+® mode had higher PEEP and lower FiO2, suggesting better recruitment of the dependent part of the lung.
Combining mechanical ventilation using the Intellivent-ASV+® mode and ECMO offers a unique opportunity of having a mechanical ventilator which automatically adapts to lung mechanics and the contribution of ECMO supporting gas exchange.
The main objective of this research project is to propose and verify whether the ventilation mode Intellivent-ASV+® is capable to execute lung protective ventilation despite the presence of an ECMO altering gas exchange.
- Being tested
- Closed Loop Mechanical Ventilation, Conventional Mechanical Ventilation
- Keywords
- ECMO, ECLS, Mechanical Ventilation, Lung Protective Ventilation, Closed Loop Ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Loop Mechanical VentilationDevice
Also called Intellivent-ASV+®
Closed loop ventilation mode (Intellivent-ASV+®). Intellivent-ASV+® was initiated by activating the controllers for minute volume, PEEP (range 5 to 18 cmH2O) and fraction of inspired oxygen (FiO2) (range 21 to 100 %). The target shift ranges for CO2-management were set between -2.5 and +2.5 kPa, and for O2-management between -2 and +2 %.
Conventional Mechanical VentilationDevice
Also called DuoPaP/ ASV
Mechanical ventilation with a conventional mode, usually either biphasic positive airway pressure ventilation (DuoPAP®) or adaptive support ventilation (ASV®)
| Study group | Role | What they receive |
|---|---|---|
| Conventional Ventilation Mode | Active comparator | Patients mechanically ventilated with a conventional mechanical ventilation mode until steady state is achieved for several hours. Receives: Device: Conventional Mechanical Ventilation |
| Closed Loop Ventilation Mode | Experimental | Once steady state on the conventional mechanical ventilation mode is achieved for several hours, switch to closed loop ventilation mode for the remainder of the study period. Receives: Device: Closed Loop Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tidal Volumes
Assessment of tidal volumes over the initial 72 hours post switch to closed loop mechanical ventilation
Measured: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Change in Driving Pressure
Assessment of Driving Pressure over the initial 72 hours post switch to closed loop mechanical ventilation
Measured: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Change in Peak Pressure
Assessment of Peak Pressure over the initial 72 hours post switch to closed loop mechanical ventilation
Measured: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Change in Mechanical Power
Assessment of Mechanical Power over the initial 72 hours post switch to closed loop mechanical ventilation
Measured: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Change in Partial Pressure of Arterial Oxygen
Assessment of Partial Pressure of Arterial Oxygen over the initial 72 hours post switch to closed loop mechanical ventilation
Measured: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Change in Partial Pressure of Arterial CO2
Assessment of Partial Pressure of Arterial CO2 over the initial 72 hours post switch to closed loop mechanical ventilation
Measured: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start6 Mar 2016
- Primary completion23 May 2018
- Study completion23 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Patients are initially mechanically ventilated with a conventional mechanical ventilation mode after ECMO installation, once steady state on the conventional mode is achieved for several hours, switch to the closed loop ventilation mode.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Maggiorini, Principal investigator, Medizinische Intensivstation D-HOER 27, UniversitatsSpital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925518
- Sponsor's protocol ID
- ECMO - IV
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ELSO Guidelines for Cardiopulmonary Extracorporeal Life Support Extracorporeal Life Support Organization, Version 1.4 August 2017 Ann Arbor, MI, USA
Richard C, Argaud L, Blet A, Boulain T, Contentin L, Dechartres A, Dejode JM, Donetti L, Fartoukh M, Fletcher D, Kuteifan K, Lasocki S, Liet JM, Lukaszewicz AC, Mal H, Maury E, Osman D, Outin H, Richard JC, Schneider F, Tamion F. Extracorporeal life support for patients with acute respiratory distress syndrome: report of a Consensus Conference. Ann Intensive Care. 2014 May 24;4:15. doi: 10.1186/2110-5820-4-15. eCollection 2014.
PubMed 24936342Pesenti A, Carlesso E, Langer T, Mauri T. Ventilation during extracorporeal support : Why and how. Med Klin Intensivmed Notfmed. 2018 Feb;113(Suppl 1):26-30. doi: 10.1007/s00063-017-0384-8. Epub 2017 Nov 28.
PubMed 29184987Serpa Neto A, Schmidt M, Azevedo LC, Bein T, Brochard L, Beutel G, Combes A, Costa EL, Hodgson C, Lindskov C, Lubnow M, Lueck C, Michaels AJ, Paiva JA, Park M, Pesenti A, Pham T, Quintel M, Marco Ranieri V, Ried M, Roncon-Albuquerque R Jr, Slutsky AS, Takeda S, Terragni PP, Vejen M, Weber-Carstens S, Welte T, Gama de Abreu M, Pelosi P, Schultz MJ; ReVA Research Network and the PROVE Network Investigators. Associations between ventilator settings during extracorporeal membrane oxygenation for refractory hypoxemia and outcome in patients with acute respiratory distress syndrome: a pooled individual patient data analysis : Mechanical ventilation during ECMO. Intensive Care Med. 2016 Nov;42(11):1672-1684. doi: 10.1007/s00134-016-4507-0. Epub 2016 Sep 1.
PubMed 27586996Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
PubMed 25693014Arnal JM, Wysocki M, Novotni D, Demory D, Lopez R, Donati S, Granier I, Corno G, Durand-Gasselin J. Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV(R)) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study. Intensive Care Med. 2012 May;38(5):781-7. doi: 10.1007/s00134-012-2548-6. Epub 2012 Mar 30.
PubMed 22460854Arnal JM, Garnero A, Novonti D, Demory D, Ducros L, Berric A, Donati S, Corno G, Jaber S, Durand-Gasselin J. Feasibility study on full closed-loop control ventilation (IntelliVent-ASV) in ICU patients with acute respiratory failure: a prospective observational comparative study. Crit Care. 2013 Sep 11;17(5):R196. doi: 10.1186/cc12890.
PubMed 24025234
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Loop Mechanical Ventilation Coupled to Extracorporeal Membrane Oxygenation Support in Therapy Refractory Acute Respiratory Distress Syndrome and Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT04925518
- Acronym / sponsor ID
- ECMO - IV
- Keywords
- ECMO, ECLS, Mechanical Ventilation, Lung Protective Ventilation, Closed Loop Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 6 Mar 2016 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 14 Jun 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.
Mechanical ventilation and ECMO are both technologies interacting on gas exchange. Nevertheless, besides a consensus paper, no evidence-based guidelines regarding protective lung ventilation on ECMO exist to date. Mechanical Ventilation with Intellivent-ASV, an algorithm driven, closed loop system, provides an opportunity to standardize ventilation on ECMO.
We propose and validate lung protective ventilation with a closed loop ventilation mode in patients with ECMO.
Detailed description
In critically ill patients admitted to the intensive care unit due to either acute respiratory failure or circulatory collapse, mechanical ventilation in combination with either extra-corporal lung assist (VV ECMO) or cardiac assist (VA ECMO) is increasingly used. Both mechanical ventilation and ECMO contribute to the control of gas exchange hence need to be adjusted accordingly.
As an assist device like a VV ECMO or a VA ECMO the control the gas exchange needs to be adjusted via sweep gas flow (ventilation), fraction of oxygen in the sweep gas (oxygenation, FsO2) and blood flow over the extracorporeal device. The combination of adaptive ventilation with ECMO is a novel concept allowing the control of oxygenation and ventilation by the adjustment of the ECMO device only.
Adaptive lung ventilation is a category of ventilation modes, which allow the control of oxygenation and ventilation with a closed loop. Using this type of ventilation modes one can control the gas exchange automatically. In terms of CO2-management they use a target minute volume to control end-tidal CO2 and adjust depending on the amount of spontaneously triggered breaths the respiratory rate and the inspiratory pressure support or solely the pressure support. In terms of O2-management according to the peripheral O2 saturation target the PEEP (lung recruitment) and the fraction of inspired oxygen (FiO2) will be set. Both of these controllers depend on an accurate measurement of either end-tidal CO2 and peripheral O2 saturation, respectively.
There exist two recommendations how to ventilate patients with ARDS on an ECMO. First and foremost, the general guidelines of the Extracorporeal Life Support Organization (ELSO) suggest for adults to target a FiO2 of less than 0.3 with a PEEP of 5 to 15 cmH2O and a plateau pressure of less than 25 cm H2O with a respiratory rate of 5 per minute. Whereas Richard et al. in their consensus conference report from 2014 suggest to minimize plateau pressure and PEEP not being specific in terms of numbers. Both guidelines have the goal of keeping the lung at rest concerning patients with ARDS. There are no specific suggestions on ventilation management in patients with heart failure on ECMO. Whether the lung has to be kept open (recruited and less prone to atelectrauma) or kept at rest (less prone to overdistension, either volu- or barotrauma) is at the moment unclear.
Concerning mechanical ventilation settings in patients with ARDS Serpa Neto and colleagues published in 2016 a meta-analysis of nine studies, which included around 550 patients receiving ECMO for refractory hypoxemia. They showed that in these patients driving pressure was associated with in-hospital survival (survivors had a driving pressure of 16.9 cmH2O and non-survivors of 19.4, p 0.004, adjusted HR 1.06 with a 95% CI of 1.03 - 1.10). This is consistent with the study of Amato et al where they showed a reduction of the multivariate relative risk of in-hospital mortality in patients with ARDS - without ECMO - with a driving pressure of less than 15 cmH2O.
The adaptive lung ventilation mode Intellivent-ASV+® has been shown to ventilate normal lungs, lungs with ARDS and COPD within the limits of safe ventilation recommended by the guidelines. Patients on Intellivent-ASV+® had tidal volumes (Vt) ≤ 8 ml/kg/BW, plateau pressure (Pplat) < 30 cmH2O and a driving pressure < 15 cmH2O. Compared to conventional ventilation, patients on Intellivent-ASV+® mode had higher PEEP and lower FiO2, suggesting better recruitment of the dependent part of the lung.
Combining mechanical ventilation using the Intellivent-ASV+® mode and ECMO offers a unique opportunity of having a mechanical ventilator which automatically adapts to lung mechanics and the contribution of ECMO supporting gas exchange.
The main objective of this research project is to propose and verify whether the ventilation mode Intellivent-ASV+® is capable to execute lung protective ventilation despite the presence of an ECMO altering gas exchange.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are initially mechanically ventilated with a conventional mechanical ventilation mode after ECMO installation, once steady state on the conventional mode is achieved for several hours, switch to the closed loop ventilation mode.
| Arm | Type | Receives |
|---|---|---|
| Conventional Ventilation Mode | Active comparator | Device: Conventional Mechanical VentilationPatients mechanically ventilated with a conventional mechanical ventilation mode until steady state is achieved for several hours. |
| Closed Loop Ventilation Mode | Experimental | Device: Closed Loop Mechanical VentilationOnce steady state on the conventional mechanical ventilation mode is achieved for several hours, switch to closed loop ventilation mode for the remainder of the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mechanical Ventilation and ECMO
- Refractory Acute Respiratory Distress Syndrome or Refractory Cardiogenic Shock
Key exclusion criteria (3 listed)
- Contraindications for ECMO
- Contraindications for Closed Loop Ventilation
- Rejection of participation
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 |
|---|---|---|
| Closed Loop Mechanical VentilationAlso: Intellivent-ASV+®Closed loop ventilation mode (Intellivent-ASV+®). Intellivent-ASV+® was initiated by activating the controllers for minute volume, PEEP (range 5 to 18 cmH2O) and fraction of inspired oxygen (FiO2) (range 21 to 100 %). The target shift ranges for CO2-management were set between -2.5 and +2.5 kPa, and for O2-management between -2 and +2 %. | Device | Closed Loop Ventilation Mode |
| Conventional Mechanical VentilationAlso: DuoPaP/ ASVMechanical ventilation with a conventional mode, usually either biphasic positive airway pressure ventilation (DuoPAP®) or adaptive support ventilation (ASV®) | Device | Conventional Ventilation Mode |
Primary outcome
Change in Tidal Volumes
Time frame: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Assessment of tidal volumes over the initial 72 hours post switch to closed loop mechanical ventilation
Change in Driving Pressure
Time frame: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Assessment of Driving Pressure over the initial 72 hours post switch to closed loop mechanical ventilation
Change in Peak Pressure
Time frame: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Assessment of Peak Pressure over the initial 72 hours post switch to closed loop mechanical ventilation
Change in Mechanical Power
Time frame: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Assessment of Mechanical Power over the initial 72 hours post switch to closed loop mechanical ventilation
Change in Partial Pressure of Arterial Oxygen
Time frame: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Assessment of Partial Pressure of Arterial Oxygen over the initial 72 hours post switch to closed loop mechanical ventilation
Change in Partial Pressure of Arterial CO2
Time frame: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours
Assessment of Partial Pressure of Arterial CO2 over the initial 72 hours post switch to closed loop mechanical ventilation
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 14 Jun 2021.
- BackgroundELSO Guidelines for Cardiopulmonary Extracorporeal Life Support Extracorporeal Life Support Organization, Version 1.4 August 2017 Ann Arbor, MI, USA
- Background: PubMed 24936342Richard C, Argaud L, Blet A, Boulain T, Contentin L, Dechartres A, Dejode JM, Donetti L, Fartoukh M, Fletcher D, Kuteifan K, Lasocki S, Liet JM, Lukaszewicz AC, Mal H, Maury E, Osman D, Outin H, Richard JC, Schneider F, Tamion F. Extracorporeal life support for patients with acute respiratory distress syndrome: report of a Consensus Conference. Ann Intensive Care. 2014 May 24;4:15. doi: 10.1186/2110-5820-4-15. eCollection 2014.
- Background: PubMed 29184987Pesenti A, Carlesso E, Langer T, Mauri T. Ventilation during extracorporeal support : Why and how. Med Klin Intensivmed Notfmed. 2018 Feb;113(Suppl 1):26-30. doi: 10.1007/s00063-017-0384-8. Epub 2017 Nov 28.
- Background: PubMed 27586996Serpa Neto A, Schmidt M, Azevedo LC, Bein T, Brochard L, Beutel G, Combes A, Costa EL, Hodgson C, Lindskov C, Lubnow M, Lueck C, Michaels AJ, Paiva JA, Park M, Pesenti A, Pham T, Quintel M, Marco Ranieri V, Ried M, Roncon-Albuquerque R Jr, Slutsky AS, Takeda S, Terragni PP, Vejen M, Weber-Carstens S, Welte T, Gama de Abreu M, Pelosi P, Schultz MJ; ReVA Research Network and the PROVE Network Investigators. Associations between ventilator settings during extracorporeal membrane oxygenation for refractory hypoxemia and outcome in patients with acute respiratory distress syndrome: a pooled individual patient data analysis : Mechanical ventilation during ECMO. Intensive Care Med. 2016 Nov;42(11):1672-1684. doi: 10.1007/s00134-016-4507-0. Epub 2016 Sep 1.
- Background: PubMed 25693014Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
- Background: PubMed 22460854Arnal JM, Wysocki M, Novotni D, Demory D, Lopez R, Donati S, Granier I, Corno G, Durand-Gasselin J. Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV(R)) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study. Intensive Care Med. 2012 May;38(5):781-7. doi: 10.1007/s00134-012-2548-6. Epub 2012 Mar 30.
- Background: PubMed 24025234Arnal JM, Garnero A, Novonti D, Demory D, Ducros L, Berric A, Donati S, Corno G, Jaber S, Durand-Gasselin J. Feasibility study on full closed-loop control ventilation (IntelliVent-ASV) in ICU patients with acute respiratory failure: a prospective observational comparative study. Crit Care. 2013 Sep 11;17(5):R196. doi: 10.1186/cc12890.
- 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.
Marco Maggiorini principal investigator
Medizinische Intensivstation D-HOER 27, UniversitatsSpital Zürich
Questions about this trial
What is this clinical trial studying?
A study testing Closed Loop Mechanical Ventilation and Conventional Mechanical Ventilation in people with Acute Respiratory Distress Syndrome and Cardiogenic Shock, run by University of Zurich.
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 2 inclusion and 3 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Tidal Volumes (time frame: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours). The study lists 6 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 NCT04925518, which also lists 7 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 14 Jun 2021.