ARDSAiRDRoPNCT03211494
Does Automated Closed-Loop Ventilation Reduce the DRiving Pressure Levels in Patients With ARDS
A study testing INTELLiVENT-ASV and Conventional lung protective ventilation in people with ARDS, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The objective of this crossover study and randomized controlled trial (RCT) is to compare ΔP levels during INTELLiVENT®-ASV with conventional lung protective ventilation in the acute and sub-acute phase of moderate or severe ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- INTELLiVENT-ASV and Conventional lung protective ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Nov 2017to 1 Mar 2019
- 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 the ICU of the AMC
- Intubated and mechanically ventilated
- Within 24 hours of initial diagnosis of ARDS
- Moderate or severe ARDS (according to the Berlin definition for ARDS)
Who cannot join
- Age < 18 years
- Patients previously included in this study
- Patients participating in other interventional trials that could influence ventilator settings and ventilation parameters
- Patients with suspected or confirmed pregnancy
- Patients with increased (of > 15 mmHg) or uncontrollable intracranial pressure
- Patients in whom esophageal pressure measurement is contra-indicated (severe bleeding diathesis, suspicion of or known pharyngeal or esophageal obstruction, esophageal ulcers, varices or strictures)
- Moribund patients
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam
About this study
Official title: Does Automated Closed-Loop Ventilation Reduce the DRiving Pressure Levels in Patients With ARDS (AiRDRoP) - a Single-Center Crossover Study and Randomized Controlled Trial
The objective of this crossover study and randomized controlled trial (RCT) is to compare ΔP levels during INTELLiVENT®-ASV with conventional lung protective ventilation in the acute and sub-acute phase of moderate or severe ARDS.
A total of 48 adult patients admitted to intensive care units with moderate or severe ARDS will be included. In the acute phase patients will receive 4 hours of INTELLiVENT-ASV ventilation and 4 hours of conventional lung protective ventilation in random order. After these two blocks the patients are allocated into either the INTELLiVENT-ASV arm or the conventional lung protective ventilation arm.
Read more
in the sub-acute phase patients will be assessed every day until day 7 or extubation, whichever comes first.
Primary endpoint is the transpulmonary transpulmonary (ΔP). Secondary endpoints of both studies include other ventilator settings and ventilation parameters, as well as time spent at a ΔP level of 15 cm H2O or higher.
Read the detailed description
- Objective:
The objective of this crossover study and randomized controlled trial (RCT) is to compare ΔP levels during INTELLiVENT®- adaptive support ventilation (ASV) with conventional lung protective ventilation in the acute and sub-acute phase of moderate or severe ARDS.
- Study design:
Single center crossover study (in the acute phase) and RCT (in the sub-acute phase).
- Study population:
The study population consists of 48 consecutive intubated and ventilation patients with moderate or severe ARDS according to the Berlin definition with an anticipated duration of mechanical ventilation of > 24 hours.
- Sample size calculation:
The sample size is computed based on the hypothesis that ventilation with INTELLiVENT®-ASV is associated with a reduction in the ΔP level of 5 cm H2O. We based this power calculation on unpublished data from a published cohort of ARDS patients29 and data from an abstract31.
For the RCT, a sample size of 20 patients in each group has 90% statistical power to detect a difference in the ΔP level of 5 cm H2O, with means of 15 and 10 cm H2O, respectively, assuming an effect size (f) of 0.4 using a repeated measures ANOVA with a 0.05 two-sided significance level.
The sample size is increased by 20% to correct for early dropouts (i.e., before day 7) and patients in whom it is impossible to measure the ΔP level, meaning that each group will contain 24 patients. Therefore, the total sample size of this study will be 48 patients.
We expect less variation in the crossover than in the RCT. Next, in this part of the study patients serve as their own control. Therefore, with this sample size we will have sufficient power for the crossover.
- Patient allocation:
Crossover study - Data will be collected during two blocks of four hours; one block of conventional lung protective ventilation, and one block of INTELLiVENT®-ASV. The two blocks will take place in randomized order. Both ventilation strategies are frequently used in our ICU. INTELLiVENT®-ASV is a relatively new ventilatory mode that was successfully implemented in our intensive care unit in 2016, especially in patients with ARDS.
Randomized controlled trial - After the crossover, patients are randomly allocated to conventional lung protective ventilation5, meaning that the ventilator is set to pressure controlled mode, or INTELLiVENT®-ASV.
- Ventilator settings:
Cross-over study
During conventional lung protective ventilation, the attending physician sets the ventilator according to the local ventilation protocol. The fraction of inspired oxygen (FiO2) is adjusted to maintain an oxygen saturation of 92 to 96% and/or a PaO2 of > 8 kPa. The respiratory rate is adjusted to maintain a blood pH of 7.25 to 7.45. The lowest level of positive end-expiratory pressure (PEEP) is 5 cm H2O; allowed PEEP-FiO2 are in concordance with the ARDS network recommendations;5 these combinations are based on two large RCTs in ARDS patients, and is standard practice in our unit.
During INTELLiVENT®-ASV, the attending physician sets the target for et-CO2 to maintain a blood pH of 7.25 to 7.45. The target for oxygen saturation is set at 92- 96%. The lowest level of PEEP is kept at 5 cm H2O.
Of note, INTELLiVENT®-ASV is available on all ventilators used in patients with ARDS. Since both ventilation strategies can be applied with these ventilators, there is no need to disconnect a patient from the ventilator. Also, switching between ventilatory modes is a standard procedure in our ICU. However, for the purpose of this study it is protocolized.
Randomized controlled trial
Settings are similar for the RCT as for the crossover study.
- Statistical analysis:
Primary study parameters
The primary outcome, the (transpulmonary) ΔP level, is analyzed using a repeated measures ANOVA. The effect mediation of ventilator parameters on the (transpulmonary) ΔP is analyzed by mediation analysis. P-values of 0.05 are used for statistical significance. When appropriate, statistical uncertainty will be expressed by the 95% confidence levels. All statistical analysis will be performed with the R language and environment for statistical computing.
Secondary study parameters
Continuous normally distributed variables will be expressed by their mean and standard deviation or when not normally distributed as medians and their interquartile ranges. Categorical variables will be expressed as n (%). To test groups Student's t test will be used, if continuous data is not normally distributed the Mann-Whitney U test will be used. Categorical variables will be compared with the Chi-square test or Fisher's exact tests. Time dependent data will be analyzed using a proportional hazard model adjusted for possible imbalances of patients' baseline characteristics. Analysis will be performed with R statistics version 3.0.2. Patient characteristics will be compared and described by appropriate statistics.
- Conditions
- ARDS
- Being tested
- INTELLiVENT-ASV, Conventional lung protective ventilation
- Keywords
- Mechanical ventilation, Driving pressure, Closed-loop ventilation, Esophageal catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTELLiVENT-ASVDevice
Also called automated closed-loop ventilation
INTELLiVENT-ASV, with software 2.60
Conventional lung protective ventilationOther
Lung protective ventilation according to the ARDSnet guidelines
| Study group | Role | What they receive |
|---|---|---|
| Conventional lung protective ventilation | Active comparator | Use of conventional lung protective ventilation, according to the ARDSnet guidelines Receives: Other: Conventional lung protective ventilation |
| INTELLiVENT-ASV | Active comparator | Use of INTELLiVENT-ASV Receives: Device: INTELLiVENT-ASV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary driving pressure level
The driving pressure of the lungs system, difference between end-inspiratory and end-expiratory pressure
Measured: during the course of mechanical ventilation (max. 7 days)
Secondary outcomes (17)
Respiratory system driving pressure level
The driving pressure of the respiratory system, difference between Pplat and PEEP
Measured: during the course of mechanical ventilation (max. 7 days)
Tidal volume
Volume of a breath
Measured: during the course of mechanical ventilation (max. 7 days)
PEEP level
Positive end-expiratory pressure
Measured: during the course of mechanical ventilation (max. 7 days)
Pplat level
Plateau pressure
Measured: during the course of mechanical ventilation (max. 7 days)
Ppeak level
Peak pressure
Measured: during the course of mechanical ventilation (max. 7 days)
RRset
set respiratory rate
Measured: during the course of mechanical ventilation (max. 7 days)
RRmeasured
measured respiratory rate
Measured: during the course of mechanical ventilation (max. 7 days)
FiO2
Fraction of inspired oxygen
Measured: during the course of mechanical ventilation (max. 7 days)
etCO2
end tidal carbondioxide
Measured: during the course of mechanical ventilation (max. 7 days)
spO2
peripheral oxygen saturation
Measured: during the course of mechanical ventilation (max. 7 days)
VCO2
volume of expired oxygen
Measured: during the course of mechanical ventilation (max. 7 days)
PaCO2
Partial pressure of arterial carbondioxide
Measured: during the course of mechanical ventilation (max. 7 days)
PaO2
Partial pressure of arterial oxygen
Measured: during the course of mechanical ventilation (max. 7 days)
saO2
arterial oxygen saturation
Measured: during the course of mechanical ventilation (max. 7 days)
pH
acidity of the arterial blood
Measured: during the course of mechanical ventilation (max. 7 days)
HCO3
Bicarbonate
Measured: during the course of mechanical ventilation (max. 7 days)
Time spent at high driving pressure
Time spent at a driving pressure of more than 14 cm H2O
Measured: during the course of mechanical ventilation (max. 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start3 Nov 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Why it stopped: Unexpected low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Medical AG
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- David MP van Meenen, MD, MSc, Study director, Department of Intensive Care, Academic Medical Center, University of AmsterdamMarcus J Schultz, MD, PhD, Principal investigator, Department of Intensive Care, Academic Medical Center, University of AmsterdamMarcello Gama de Abreu, MD, PhD, Study chair, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, GermanyAry Serpa Neto, MD, MSc, Study chair, Department of Intensive Care, Academic Medical Center, University of Amsterdam, The NetherlandsPaolo Pelosi, MD, PhD, Principal investigator, Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, ItalyJitske R Rogmans, Principal investigator, Department of Intensive Care, Academic Medical Center, University of AmsterdamLennard HL Pennekamp, Principal investigator, Department of Intensive Care, Academic Medical Center, University of AmsterdamFrank C Dullemeijer, Principal investigator, Department of Intensive Care, Academic Medical Center, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211494
- Sponsor's protocol ID
- AiRDRoP
- Acronym
- AiRDRoP
- Status last verified
- Mar 2019
- First submitted
- 6 Jul 2017
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Buiteman-Kruizinga LA, van Meenen DMP, Bos LDJ, van der Heiden PLJ, Paulus F, Schultz MJ. A closed-loop ventilation mode that targets the lowest work and force of breathing reduces the transpulmonary driving pressure in patients with moderate-to-severe ARDS. Intensive Care Med Exp. 2023 Jul 14;11(1):42. doi: 10.1186/s40635-023-00527-1.
PubMed 37442844
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Automated Closed-Loop Ventilation Reduce the DRiving Pressure Levels in Patients With ARDS (AiRDRoP) - a Single-Center Crossover Study and Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03211494
- Acronym / sponsor ID
- AiRDRoP / AiRDRoP
- Conditions
- ARDS
- Keywords
- Mechanical ventilation, Driving pressure, Closed-loop ventilation, Esophageal catheter
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unexpected low recruitment rate
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Hamilton Medical AG
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 7 Jul 2017 (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.
The objective of this crossover study and randomized controlled trial (RCT) is to compare ΔP levels during INTELLiVENT®-ASV with conventional lung protective ventilation in the acute and sub-acute phase of moderate or severe ARDS.
A total of 48 adult patients admitted to intensive care units with moderate or severe ARDS will be included. In the acute phase patients will receive 4 hours of INTELLiVENT-ASV ventilation and 4 hours of conventional lung protective ventilation in random order. After these two blocks the patients are allocated into either the INTELLiVENT-ASV arm or the conventional lung protective ventilation arm.
in the sub-acute phase patients will be assessed every day until day 7 or extubation, whichever comes first.
Primary endpoint is the transpulmonary transpulmonary (ΔP). Secondary endpoints of both studies include other ventilator settings and ventilation parameters, as well as time spent at a ΔP level of 15 cm H2O or higher.
Detailed description
- Objective:
The objective of this crossover study and randomized controlled trial (RCT) is to compare ΔP levels during INTELLiVENT®- adaptive support ventilation (ASV) with conventional lung protective ventilation in the acute and sub-acute phase of moderate or severe ARDS.
- Study design:
Single center crossover study (in the acute phase) and RCT (in the sub-acute phase).
- Study population:
The study population consists of 48 consecutive intubated and ventilation patients with moderate or severe ARDS according to the Berlin definition with an anticipated duration of mechanical ventilation of > 24 hours.
- Sample size calculation:
The sample size is computed based on the hypothesis that ventilation with INTELLiVENT®-ASV is associated with a reduction in the ΔP level of 5 cm H2O. We based this power calculation on unpublished data from a published cohort of ARDS patients29 and data from an abstract31.
For the RCT, a sample size of 20 patients in each group has 90% statistical power to detect a difference in the ΔP level of 5 cm H2O, with means of 15 and 10 cm H2O, respectively, assuming an effect size (f) of 0.4 using a repeated measures ANOVA with a 0.05 two-sided significance level.
The sample size is increased by 20% to correct for early dropouts (i.e., before day 7) and patients in whom it is impossible to measure the ΔP level, meaning that each group will contain 24 patients. Therefore, the total sample size of this study will be 48 patients.
We expect less variation in the crossover than in the RCT. Next, in this part of the study patients serve as their own control. Therefore, with this sample size we will have sufficient power for the crossover.
- Patient allocation:
Crossover study - Data will be collected during two blocks of four hours; one block of conventional lung protective ventilation, and one block of INTELLiVENT®-ASV. The two blocks will take place in randomized order. Both ventilation strategies are frequently used in our ICU. INTELLiVENT®-ASV is a relatively new ventilatory mode that was successfully implemented in our intensive care unit in 2016, especially in patients with ARDS.
Randomized controlled trial - After the crossover, patients are randomly allocated to conventional lung protective ventilation5, meaning that the ventilator is set to pressure controlled mode, or INTELLiVENT®-ASV.
- Ventilator settings:
Cross-over study
During conventional lung protective ventilation, the attending physician sets the ventilator according to the local ventilation protocol. The fraction of inspired oxygen (FiO2) is adjusted to maintain an oxygen saturation of 92 to 96% and/or a PaO2 of > 8 kPa. The respiratory rate is adjusted to maintain a blood pH of 7.25 to 7.45. The lowest level of positive end-expiratory pressure (PEEP) is 5 cm H2O; allowed PEEP-FiO2 are in concordance with the ARDS network recommendations;5 these combinations are based on two large RCTs in ARDS patients, and is standard practice in our unit.
During INTELLiVENT®-ASV, the attending physician sets the target for et-CO2 to maintain a blood pH of 7.25 to 7.45. The target for oxygen saturation is set at 92- 96%. The lowest level of PEEP is kept at 5 cm H2O.
Of note, INTELLiVENT®-ASV is available on all ventilators used in patients with ARDS. Since both ventilation strategies can be applied with these ventilators, there is no need to disconnect a patient from the ventilator. Also, switching between ventilatory modes is a standard procedure in our ICU. However, for the purpose of this study it is protocolized.
Randomized controlled trial
Settings are similar for the RCT as for the crossover study.
- Statistical analysis:
Primary study parameters
The primary outcome, the (transpulmonary) ΔP level, is analyzed using a repeated measures ANOVA. The effect mediation of ventilator parameters on the (transpulmonary) ΔP is analyzed by mediation analysis. P-values of 0.05 are used for statistical significance. When appropriate, statistical uncertainty will be expressed by the 95% confidence levels. All statistical analysis will be performed with the R language and environment for statistical computing.
Secondary study parameters
Continuous normally distributed variables will be expressed by their mean and standard deviation or when not normally distributed as medians and their interquartile ranges. Categorical variables will be expressed as n (%). To test groups Student's t test will be used, if continuous data is not normally distributed the Mann-Whitney U test will be used. Categorical variables will be compared with the Chi-square test or Fisher's exact tests. Time dependent data will be analyzed using a proportional hazard model adjusted for possible imbalances of patients' baseline characteristics. Analysis will be performed with R statistics version 3.0.2. Patient characteristics will be compared and described by appropriate statistics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional lung protective ventilation | Active comparator | Other: Conventional lung protective ventilationUse of conventional lung protective ventilation, according to the ARDSnet guidelines |
| INTELLiVENT-ASV | Active comparator | Device: INTELLiVENT-ASVUse of INTELLiVENT-ASV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission to the ICU of the AMC
- Intubated and mechanically ventilated
- Within 24 hours of initial diagnosis of ARDS
- Moderate or severe ARDS (according to the Berlin definition for ARDS)
Key exclusion criteria (7 listed)
- Age < 18 years
- Patients previously included in this study
- Patients participating in other interventional trials that could influence ventilator settings and ventilation parameters
- Patients with suspected or confirmed pregnancy
- Patients with increased (of > 15 mmHg) or uncontrollable intracranial pressure
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-ASVAlso: automated closed-loop ventilationINTELLiVENT-ASV, with software 2.60 | Device | INTELLiVENT-ASV |
| Conventional lung protective ventilationLung protective ventilation according to the ARDSnet guidelines | Other | Conventional lung protective ventilation |
Primary outcome
Transpulmonary driving pressure level
Time frame: during the course of mechanical ventilation (max. 7 days)
The driving pressure of the lungs system, difference between end-inspiratory and end-expiratory pressure
17 secondary outcomes
Respiratory system driving pressure level
Time frame: during the course of mechanical ventilation (max. 7 days)
Tidal volume
Time frame: during the course of mechanical ventilation (max. 7 days)
PEEP level
Time frame: during the course of mechanical ventilation (max. 7 days)
Pplat level
Time frame: during the course of mechanical ventilation (max. 7 days)
Ppeak level
Time frame: during the course of mechanical ventilation (max. 7 days)
RRset
Time frame: during the course of mechanical ventilation (max. 7 days)
RRmeasured
Time frame: during the course of mechanical ventilation (max. 7 days)
FiO2
Time frame: during the course of mechanical ventilation (max. 7 days)
etCO2
Time frame: during the course of mechanical ventilation (max. 7 days)
spO2
Time frame: during the course of mechanical ventilation (max. 7 days)
VCO2
Time frame: during the course of mechanical ventilation (max. 7 days)
PaCO2
Time frame: during the course of mechanical ventilation (max. 7 days)
PaO2
Time frame: during the course of mechanical ventilation (max. 7 days)
saO2
Time frame: during the course of mechanical ventilation (max. 7 days)
pH
Time frame: during the course of mechanical ventilation (max. 7 days)
HCO3
Time frame: during the course of mechanical ventilation (max. 7 days)
Time spent at high driving pressure
Time frame: during the course of mechanical ventilation (max. 7 days)
Results and safety
The study was stopped early (reason given: Unexpected low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Derived from this study: PubMed 37442844Buiteman-Kruizinga LA, van Meenen DMP, Bos LDJ, van der Heiden PLJ, Paulus F, Schultz MJ. A closed-loop ventilation mode that targets the lowest work and force of breathing reduces the transpulmonary driving pressure in patients with moderate-to-severe ARDS. Intensive Care Med Exp. 2023 Jul 14;11(1):42. doi: 10.1186/s40635-023-00527-1.
- 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.
David MP van Meenen, MD, MSc study director
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Marcus J Schultz, MD, PhD principal investigator
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Marcello Gama de Abreu, MD, PhD study chair
Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTELLiVENT-ASV and Conventional lung protective ventilation in people with ARDS, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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: stopped early, as of the sponsor's last update on 5 Mar 2019. 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 Netherlands. 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 was stopped early (reason given: Unexpected low recruitment rate). Results are not available in the source record.
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?
Transpulmonary driving pressure level (time frame: during the course of mechanical ventilation (max. 7 days)). 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 NCT03211494, which also lists 1 linked publication.
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 5 Mar 2019.