Ventilator-free DaysACTiVENCT04593810
Effect of Automated Closed-Loop Ventilation Versus Conventional Ventilation on Duration and Quality of Ventilation
A study testing INTELLiVENT-ASV and CONVENTIONAL VENTILATION in people with Ventilator-free Days and Quality of Breathing, run by Prof. Dr. Marcus J. Schultz at 10 sites in 2 countries.
Trial summary
INTELLiVENT-Adaptive Support Ventilation (ASV) is a fully automated closed-loop mode of mechanical ventilation available on commercial ventilators. Evidence for clinical benefit of INTELLiVENT-ASV in comparison to non-automated ventilation is lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-free Days, Quality of Breathing
- What is being tested?
- INTELLiVENT-ASV and CONVENTIONAL VENTILATION
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,201 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 19 Oct 2020to 16 Sep 2025
- 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
- admission to one of the participating ICUs
- intubated and receiving invasive ventilation
- anticipated duration of ventilation of at least 24 hours
Who cannot join
- age below 18 years
- patients with suspected or confirmed pregnancy
- invasive ventilation > 1 hour in the ICU
- invasive ventilation > 6 hours directly preceding the current ICU admission
- participation in another interventional trial using similar endpoints
- after recent pneumectomy or lobectomy
Show all 14Show fewer
- morbid obesity (body mass index > 40 kg/m2)
- premorbid restrictive pulmonary disease
- unreliable pulse oximetry (secondary to carbon monoxide poisoning or sickle cell disease)
- any neurologic diagnosis that can prolong duration of mechanical ventilation, e.g., Guillain-Barré syndrome, high spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis
- patients receiving or planned to receive veno-venous, veno-arterial or arterio-venous extracorporeal membrane oxygenation (ECMO)
- unavailability of INTELLiVENT-ASV (no ventilator available with this ventilation mode)
- previously randomized in this study
- no informed consent
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Netherlands8 sites
Flevoziekenhuis
Almere Stad
Academic Medical Center, Intensive Care
Amsterdam
Reinier de Graaf Gasthuis
Delft
Catharina Ziekenhuis
Eindhoven
Leiden UMC
Leiden
Canisius-Wilhelmina Hospital
Nijmegen
Elisabeth-TweeSteden Ziekenhuis
Tilburg
Diakonessenhuis, Utrecht
Utrecht
Italy2 sites
Ospedale Policlinico San Martino
Genoa
Policlinico San Matteo Fondazione IRCCS
Pavia
About this study
Official title: Effect of Automated Closed-Loop Ventilation Versus Conventional Ventilation on Duration and Quality of Ventilation ('ACTiVE') - a Randomized Clinical Trial in Intensive Care Unit Patients
INTELLiVENT-Adaptive Support Ventilation (ASV) is a fully automated closed-loop mode of mechanical ventilation available on commercial ventilators. Evidence for clinical benefit of INTELLiVENT-ASV in comparison to non-automated ventilation is lacking.
The ACTiVE study is an international, multicenter, randomized controlled trial in invasively ventilated ICU patients with the objective to compare INTELLiVENT-ASV to conventional ventilation. We hypothesise that INTELLiVENT-ASV shortens the duration of ventilation. The secondary hypothesis is that INTELLiVENT-ASV improves the quality of breathing.
Read the detailed description
Objective
The primary objective of this trial is to compare INTELLiVENT-ASV with non-automated ventilation in critically ill intensive care unit (ICU) patients with respect to ventilation duration. One secondary aim is to test whether INTELLiVENT-ASV improves quality of breathing, expressed as the proportion of breath within lung-protective margins, in a time frame of 24 hours early after start of invasive ventilation.
Study design
International, multicenter, superiority randomized clinical trial in critically ill, intubated and ventilated adult ICU patients with an anticipated duration of ventilation of at least 24 hours.
Study population
Adult patients admitted to ICUs in the Netherlands and Italy.
Sample size calculation
The sample size is based on the hypothesis that INTELLiVENT-ASV will shorten ventilation duration by 1.5 days with no changes in mortality rate. Based on previously performed studies a sample of 1,200 patients (600 in each treatment group) is needed to have beta of 80% power and a two-tailed alpha of 0.05, to detect a mean between-group difference of 1.5 VFD-28, allowing a dropout rate of 5%. By including 1,200 patients, this study will be sufficiently powered to detect differences in the secondary endpoint, which is quality of breathing.
Methods:
Within one hour of start of ventilation in the ICU, patients are randomly assigned in a 1:1 ratio to INTELLiVENT-ASV or non-automated ventilation. Randomization will be stratified by center. As soon as possible after randomization, but within a maximum of 72 hours, deferred consent is obtained from the legal representative of the patient.
INTELLiVENT-ASV In patients who are randomized to INTELLiVENT-ASV, the ventilator is switched to this fully automated mode as soon possible. The sensors for end-tidal carbon dioxide (ETCO2) and pulse oximetry (SpO2) are connected and activated in the ventilator. Patient's gender and height are set on the ventilator and patient condition is chosen if applicable. If needed, the targets zones for ETCO2 and SpO2 are adjusted. The default alarm limits are accepted.
It is advised to enable QuickWean in all patients. The use of the automated Spontaneous Breathing Trial (SBT) function is left to the discretion of the clinician.
CONVENTIONAL VENTILATION Patients who are randomized to conventional ventilation will be ventilated with a mode that is not fully automated, thus standard volume controlled (VCV) or pressure controlled ventilation (PCV), and pressure support ventilation (PSV), depending on patient's activity. None of the following semi or fully automated modes of ventilation is allowed at any time: Neurally Adjusted Ventilatory Assist (NAVA), SmartCare/PS, Proportional Assist Ventilation (PAV), or the predecessor of INTELLiVENT-ASV named ASV.
In all patients who receive assist ventilation (i.e., VCV or PCV), three times a day it should be checked whether the patient can accept supported ventilation (i.e., PSV); this should also be tried when the patient shows respiratory muscle activity during assist ventilation, or in case of patient-ventilator asynchrony.
Patients can be subjected to SBTs using either a T-piece or ventilation with minimal support (pressure support level < 10 cm H2O). An SBT is deemed successful when the following criteria are met for at least 30 minutes, i.e., respiratory rate < 35/min, peripheral oxygen saturation > 90%, increase < 20% of heart rate and blood pressure, and no signs of anxiety and diaphoresis.
In both groups patients are extubated if standard extubation criteria are fulfilled, i.e., normal body temperature, patient awake and responsive/cooperative, adequate cough reflex, adequate oxygenation, hemodynamically stable, and adequate lung function.
- Conditions
- Ventilator-free Days, Quality of Breathing
- Being tested
- INTELLiVENT-ASV, CONVENTIONAL VENTILATION
- Keywords
- Automated invasive ventilation, Closed-loop invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTELLiVENT-ASVProcedure or surgery
INTELLiVENT-ASV is activated as soon possible. The sensors for ETCO2 and SpO2 are connected and activated. Patient's gender and height are set on the ventilator and patient condition is chosen if applicable.
CONVENTIONAL VENTILATIONProcedure or surgery
Conventional ventilation consists of VCV or PCV and PSV, depending on patient's activity. None of the semi or fully automated modes of ventilation is allowed at any time.
| Study group | Role | What they receive |
|---|---|---|
| INTELLiVENT-ASV | Experimental | Use of INTELLIVENT-ASV after intubation and during all mechanical ventilation in the ICU. Receives: Procedure: INTELLiVENT-ASV |
| Conventional ventilation | Active comparator | Use of conventional ventilation after intubation and during all mechanical ventilation in the ICU. Receives: Procedure: CONVENTIONAL VENTILATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days and alive at day 28
The number of days from day 1 to day 28 the patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours
Measured: first 28 days after start of ventilation
Secondary outcomes (9)
Quality of breathing
Proportion of breaths within lung-protective margins
Measured: 24 hours early after start of invasive ventilation.
Duration of ventilation
Duration of ventilation in survivors
Measured: first 28 days after start of ventilation
Length of stay
Length of stay in the intensive care unit and in the hospital
Measured: first 90 days after start of ventilation
Mortality
Any death during ICU- or hospital-stay, at day 28 and day 90
Measured: first 90 days after start of ventilation
Pulmonary complications
Development of ARDS, severe hypoxemia, severe hypercapnia, severe atelectasis, pneumothorax and ventilator-associated pneumonia
Measured: daily until ICU discharge or day 28
Rescue therapies for severe hypoxemia or severe atelectasis
Incidence of use of rescue therapies for severe hypoxemia or severe atelectasis: recruitment maneuver, prone positioning, bronchoscopy for opening atelectasis
Measured: daily until ICU discharge or day 28
Extubation failure
Extubation with need for reintubation within 24 hours
Measured: daily until ICU discharge or day 28
Maximal inspiratory pressure (MIP)
Maximal inspiratory pressure measured after extubation at centers that can collect this data
Measured: within 24 hours after extubation
Quality of Life questionnaire
The European Quality of life 5 Dimensions 5 Levels questionnaire (EQ-5D-5L) is used to assess health-related quality of life status in adults. It consists of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels (from 1 to 5) that are described by statements appropriate to that dimension. Higher values mean worse quality of life. The evaluation includes a visual analogue scale to quantitative measure the overall health status. This scale has a range from 0 to 100.
Measured: day 28 after start of ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start19 Oct 2020
- Primary completion16 Jul 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator-free DaysStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Marcus J. Schultz
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Catharina Ziekenhuis Eindhoven, Reinier de Graaf Groep, Flevoziekenhuis, Leiden University Medical Center, Canisius-Wilhelmina Hospital, Elisabeth-TweeSteden Ziekenhuis, Diakonessenhuis, Utrecht, Ospedale Policlinico San Martino, Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Sponsor-investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Janneke Horn, MD, PhD, Principal investigator, Department of Intensive Care, Academic Medical CenterFrederique Paulus, PhD, Study director, Department of Intensive Care, Academic Medical CenterMarcus J Schultz, MD,PhD, Study director, Department of Intensive Care, Academic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593810
- Sponsor's protocol ID
- ACTiVE
- Acronym
- ACTiVE
- Status last verified
- Jan 2025
- First submitted
- 11 Oct 2020
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sinnige JS, Buiteman-Kruizinga LA, Horn J, Paulus F, Schultz MJ, Serpa Neto A; ACTiVE Investigators and the Protective Ventilation Network. Effect of Automated Closed-Loop Ventilation vs Protocolized Conventional Ventilation on Ventilator-Free Days in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2026 Mar 10;335(10):874-884. doi: 10.1001/jama.2025.24384.
PubMed 41361939Botta M, Tsonas AM, Sinnige JS, De Bie AJR, Bindels AJGH, Ball L, Battaglini D, Brunetti I, Buiteman-Kruizinga LA, van der Heiden PLJ, de Jonge E, Mojoli F, Robba C, Schoe A, Paulus F, Pelosi P, Neto AS, Horn J, Schultz MJ; ACTiVE collaborative group. Effect of Automated Closed-loop ventilation versus convenTional VEntilation on duration and quality of ventilation in critically ill patients (ACTiVE) - study protocol of a randomized clinical trial. Trials. 2022 Apr 23;23(1):348. doi: 10.1186/s13063-022-06286-w.
PubMed 35461264
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Automated Closed-Loop Ventilation Versus Conventional Ventilation on Duration and Quality of Ventilation ('ACTiVE') - a Randomized Clinical Trial in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT04593810
- Acronym / sponsor ID
- ACTiVE / ACTiVE
- Conditions
- Ventilator-free Days, Quality of Breathing
- Keywords
- Automated invasive ventilation, Closed-loop invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,201 participants (actual)
- Lead sponsor
- Prof. Dr. Marcus J. SchultzUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Catharina Ziekenhuis Eindhoven, Reinier de Graaf Groep, Flevoziekenhuis, Leiden University Medical Center, Canisius-Wilhelmina Hospital, Elisabeth-TweeSteden Ziekenhuis, Diakonessenhuis, Utrecht, Ospedale Policlinico San Martino, Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 20 Oct 2020 (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.
INTELLiVENT-Adaptive Support Ventilation (ASV) is a fully automated closed-loop mode of mechanical ventilation available on commercial ventilators. Evidence for clinical benefit of INTELLiVENT-ASV in comparison to non-automated ventilation is lacking.
The ACTiVE study is an international, multicenter, randomized controlled trial in invasively ventilated ICU patients with the objective to compare INTELLiVENT-ASV to conventional ventilation. We hypothesise that INTELLiVENT-ASV shortens the duration of ventilation. The secondary hypothesis is that INTELLiVENT-ASV improves the quality of breathing.
Detailed description
Objective
The primary objective of this trial is to compare INTELLiVENT-ASV with non-automated ventilation in critically ill intensive care unit (ICU) patients with respect to ventilation duration. One secondary aim is to test whether INTELLiVENT-ASV improves quality of breathing, expressed as the proportion of breath within lung-protective margins, in a time frame of 24 hours early after start of invasive ventilation.
Study design
International, multicenter, superiority randomized clinical trial in critically ill, intubated and ventilated adult ICU patients with an anticipated duration of ventilation of at least 24 hours.
Study population
Adult patients admitted to ICUs in the Netherlands and Italy.
Sample size calculation
The sample size is based on the hypothesis that INTELLiVENT-ASV will shorten ventilation duration by 1.5 days with no changes in mortality rate. Based on previously performed studies a sample of 1,200 patients (600 in each treatment group) is needed to have beta of 80% power and a two-tailed alpha of 0.05, to detect a mean between-group difference of 1.5 VFD-28, allowing a dropout rate of 5%. By including 1,200 patients, this study will be sufficiently powered to detect differences in the secondary endpoint, which is quality of breathing.
Methods:
Within one hour of start of ventilation in the ICU, patients are randomly assigned in a 1:1 ratio to INTELLiVENT-ASV or non-automated ventilation. Randomization will be stratified by center. As soon as possible after randomization, but within a maximum of 72 hours, deferred consent is obtained from the legal representative of the patient.
INTELLiVENT-ASV In patients who are randomized to INTELLiVENT-ASV, the ventilator is switched to this fully automated mode as soon possible. The sensors for end-tidal carbon dioxide (ETCO2) and pulse oximetry (SpO2) are connected and activated in the ventilator. Patient's gender and height are set on the ventilator and patient condition is chosen if applicable. If needed, the targets zones for ETCO2 and SpO2 are adjusted. The default alarm limits are accepted.
It is advised to enable QuickWean in all patients. The use of the automated Spontaneous Breathing Trial (SBT) function is left to the discretion of the clinician.
CONVENTIONAL VENTILATION Patients who are randomized to conventional ventilation will be ventilated with a mode that is not fully automated, thus standard volume controlled (VCV) or pressure controlled ventilation (PCV), and pressure support ventilation (PSV), depending on patient's activity. None of the following semi or fully automated modes of ventilation is allowed at any time: Neurally Adjusted Ventilatory Assist (NAVA), SmartCare/PS, Proportional Assist Ventilation (PAV), or the predecessor of INTELLiVENT-ASV named ASV.
In all patients who receive assist ventilation (i.e., VCV or PCV), three times a day it should be checked whether the patient can accept supported ventilation (i.e., PSV); this should also be tried when the patient shows respiratory muscle activity during assist ventilation, or in case of patient-ventilator asynchrony.
Patients can be subjected to SBTs using either a T-piece or ventilation with minimal support (pressure support level < 10 cm H2O). An SBT is deemed successful when the following criteria are met for at least 30 minutes, i.e., respiratory rate < 35/min, peripheral oxygen saturation > 90%, increase < 20% of heart rate and blood pressure, and no signs of anxiety and diaphoresis.
In both groups patients are extubated if standard extubation criteria are fulfilled, i.e., normal body temperature, patient awake and responsive/cooperative, adequate cough reflex, adequate oxygenation, hemodynamically stable, and adequate lung function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTELLiVENT-ASV | Experimental | Procedure: INTELLiVENT-ASVUse of INTELLIVENT-ASV after intubation and during all mechanical ventilation in the ICU. |
| Conventional ventilation | Active comparator | Procedure: CONVENTIONAL VENTILATIONUse of conventional ventilation after intubation and during all mechanical ventilation in the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- admission to one of the participating ICUs
- intubated and receiving invasive ventilation
- anticipated duration of ventilation of at least 24 hours
Key exclusion criteria (14 listed)
- age below 18 years
- patients with suspected or confirmed pregnancy
- invasive ventilation > 1 hour in the ICU
- invasive ventilation > 6 hours directly preceding the current ICU admission
- participation in another interventional trial using similar endpoints
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 |
|---|---|---|
| INTELLiVENT-ASVINTELLiVENT-ASV is activated as soon possible. The sensors for ETCO2 and SpO2 are connected and activated. Patient's gender and height are set on the ventilator and patient condition is chosen if applicable. | Procedure or surgery | INTELLiVENT-ASV |
| CONVENTIONAL VENTILATIONConventional ventilation consists of VCV or PCV and PSV, depending on patient's activity. None of the semi or fully automated modes of ventilation is allowed at any time. | Procedure or surgery | Conventional ventilation |
Primary outcome
Ventilator-free days and alive at day 28
Time frame: first 28 days after start of ventilation
The number of days from day 1 to day 28 the patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours
9 secondary outcomes
Quality of breathing
Time frame: 24 hours early after start of invasive ventilation.
Duration of ventilation
Time frame: first 28 days after start of ventilation
Length of stay
Time frame: first 90 days after start of ventilation
Mortality
Time frame: first 90 days after start of ventilation
Pulmonary complications
Time frame: daily until ICU discharge or day 28
Rescue therapies for severe hypoxemia or severe atelectasis
Time frame: daily until ICU discharge or day 28
Extubation failure
Time frame: daily until ICU discharge or day 28
Maximal inspiratory pressure (MIP)
Time frame: within 24 hours after extubation
Quality of Life questionnaire
Time frame: day 28 after start of 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 11 Mar 2026.
- Derived from this study: PubMed 41361939Sinnige JS, Buiteman-Kruizinga LA, Horn J, Paulus F, Schultz MJ, Serpa Neto A; ACTiVE Investigators and the Protective Ventilation Network. Effect of Automated Closed-Loop Ventilation vs Protocolized Conventional Ventilation on Ventilator-Free Days in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2026 Mar 10;335(10):874-884. doi: 10.1001/jama.2025.24384.
- Derived from this study: PubMed 35461264Botta M, Tsonas AM, Sinnige JS, De Bie AJR, Bindels AJGH, Ball L, Battaglini D, Brunetti I, Buiteman-Kruizinga LA, van der Heiden PLJ, de Jonge E, Mojoli F, Robba C, Schoe A, Paulus F, Pelosi P, Neto AS, Horn J, Schultz MJ; ACTiVE collaborative group. Effect of Automated Closed-loop ventilation versus convenTional VEntilation on duration and quality of ventilation in critically ill patients (ACTiVE) - study protocol of a randomized clinical trial. Trials. 2022 Apr 23;23(1):348. doi: 10.1186/s13063-022-06286-w.
- Individual participant dataSharing planned: Undecided
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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.
Janneke Horn, MD, PhD principal investigator
Department of Intensive Care, Academic Medical Center
Frederique Paulus, PhD study director
Department of Intensive Care, Academic Medical Center
Marcus J Schultz, MD,PhD study director
Department of Intensive Care, Academic Medical Center
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTELLiVENT-ASV and CONVENTIONAL VENTILATION in people with Ventilator-free Days and Quality of Breathing, run by Prof. Dr. Marcus J. Schultz at 10 sites in 2 countries.
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 3 inclusion and 14 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands, Italy. 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?
Ventilator-free days and alive at day 28 (time frame: first 28 days after start of ventilation). 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 NCT04593810, which also lists 2 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 11 Mar 2026.