ARDSNCT03764319
Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO
A study testing Ultra-protective ventilator settings and Standard ventilator settings in people with ARDS and Acute Lung Injury, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The acute respiratory distress syndrome (ARDS) is the most severe form of respiratory failure, presented in 10% of all intensive care patients and carrying a high mortality rate. Extracorporeal membrane oxygenation (ECMO) is a rescue treatment for patients with severe ARDS. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- ARDS, Acute Lung Injury, Extracorporeal Membrane Oxygenation
- What is being tested?
- Ultra-protective ventilator settings and Standard ventilator settings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteAustria
- Study dates
- 6 Nov 2018to 1 Aug 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe ARDS - Partial pressure of oxygen/Fraction of inspired oxygen (PaO2/FiO2) < 200 mmHg
- ECMO < 24 hours in situ
- Gender-matched
- Age-matched
Who cannot join
- BMI > 40
- Expected weaning of ECMO < 3 days (postoperative ECMO)
- Combustion
- Restrictive chest wall impairment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine
Vienna, Austria, 1090
About this study
Official title: Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With Severe Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation: a Prospective, Randomized, Clinical Trial
The acute respiratory distress syndrome (ARDS) is the most severe form of respiratory failure, presented in 10% of all intensive care patients and carrying a high mortality rate. Extracorporeal membrane oxygenation (ECMO) is a rescue treatment for patients with severe ARDS. Mechanical ventilator settings in patients with severe ARDS during ECMO therapy are not clearly defined at the moment.
Read the detailed description
The aim of this study is to assess the effect of a rigorous low breathing frequency and ultra-low tidal volume ventilation strategy on clinical outcome, compared to standard ventilator settings following the recent guidelines in patients with severe ARDS treated with ECMO.
The hypothesis is that a low breathing frequency and ultra-low tidal volume ventilation strategy is more protective for the ARDS challenged lung and reduces the duration of mechanical ventilation and so increases the ventilator free days in patients with severe ARDS treated with ECMO.
- Conditions
- ARDS, Acute Lung Injury, Extracorporeal Membrane Oxygenation, Respiratory Distress Syndrome, Respiratory Tract Diseases, Lung Diseases
- Being tested
- Ultra-protective ventilator settings, Standard ventilator settings
- Keywords
- ARDS, ECMO, Ventilation
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Respiratory Tract Diseases, Lung Diseases, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-protective ventilator settingsOther
4-5 Breaths per minute; 14-16 cmH2O Positive endexpiratory pressure (PEEP) (adjust PEEP to 23 < Plateau pressure < 25 cmH2O); 23-25 cmH2O Plateau pressure (adjust to not exceed Tidal volume > 4 mL/kg Predicted body weight (PBW)); < 4mL/kg PBW Tidal volume; 1:5 Inspiration:Expiration (I:E)
Standard ventilator settingsOther
12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Ultra-protective ventilator settings in patients with ARDS and ECMO. Receives: Other: Ultra-protective ventilator settings |
| Control group | Active comparator | Standard ventilator settings in patients with ARDS and ECMO. Receives: Other: Standard ventilator settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days
Ventilator free days
Measured: Immediately after initiation of ECMO up to 28 days
Time from randomization to fulfillment of extubation criteria
Time from randomization (initiation of ECMO) to fulfillment of the extubation criteria:
- ARDS resolved
- Temperature ≥ 36°C and ≤ 39°C
- Low FiO2 (< 0.5)
- PEEP (< 8 cmH2O) requirement
- Able to initiate spontaneous breaths
- Tidalvolume > 5 mL/kg or > 325 mL
- Minute ventilation 5-6 L/min
- PaO2/FiO2 > 200 mmHg
- pH ≥ 7.25
- Ability to cough after deflating tube cuff
- Respiratory rate 8-30/min
- Hemodynamic stability
Measured: Immediately after initiation of ECMO up to 28 days
Secondary outcomes (8)
Total time of mechanical ventilation
Total time of mechanical ventilation
Measured: Start of mechanical ventilation up to 28 days
28 day mortality
Mortality from initiation of ECMO till day 28 after initiation of ECMO
Measured: Immediately after initiation of ECMO up to 28 days
One year mortality
Mortality from initiation of ECMO till one year after initiation of ECMO
Measured: Immediately after initiation of ECMO up to one year
Incidence of reintubation
Incidence of reintubation
Measured: Immediately after initiation of ECMO up to 28 days
Length of ICU stay
Length of ICU stay
Measured: Immediately after initiation of ECMO
Evaluation of RAS, ACE, ACE2.
Analyses of leftover blood. Renin angiotensin system (RAS) and Angiotensin converting enzyme (ACE) evaluation.
Measured: 2 months
Evaluation of Cytokines in pg/ml
IL-6, IL-8, TNFR1, RAGE, Protein C
Measured: 2 months
Evaluation of vitamin D status
25(OH), 1,25(OH)
Measured: Length of ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start6 Nov 2018
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of 2 groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Hermann, Medical University of Vienna
- Investigators
- Roman Ullrich, Ao.Univ.Prof., Principal investigator, Department of Anesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764319
- Sponsor's protocol ID
- MUVienna ARDS-ECMO
- Status last verified
- Sep 2021
- First submitted
- 29 Nov 2018
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With Severe Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation: a Prospective, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT03764319
- Acronym / sponsor ID
- MUVienna ARDS-ECMO
- Conditions
- ARDS, Acute Lung Injury, Extracorporeal Membrane Oxygenation, Respiratory Distress Syndrome, Respiratory Tract Diseases, Lung Diseases
- Keywords
- ARDS, ECMO, Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 5 Dec 2018 (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 acute respiratory distress syndrome (ARDS) is the most severe form of respiratory failure, presented in 10% of all intensive care patients and carrying a high mortality rate. Extracorporeal membrane oxygenation (ECMO) is a rescue treatment for patients with severe ARDS. Mechanical ventilator settings in patients with severe ARDS during ECMO therapy are not clearly defined at the moment.
Detailed description
The aim of this study is to assess the effect of a rigorous low breathing frequency and ultra-low tidal volume ventilation strategy on clinical outcome, compared to standard ventilator settings following the recent guidelines in patients with severe ARDS treated with ECMO.
The hypothesis is that a low breathing frequency and ultra-low tidal volume ventilation strategy is more protective for the ARDS challenged lung and reduces the duration of mechanical ventilation and so increases the ventilator free days in patients with severe ARDS treated with ECMO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of 2 groups
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Ultra-protective ventilator settingsUltra-protective ventilator settings in patients with ARDS and ECMO. |
| Control group | Active comparator | Other: Standard ventilator settingsStandard ventilator settings in patients with ARDS and ECMO. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate to severe ARDS - Partial pressure of oxygen/Fraction of inspired oxygen (PaO2/FiO2) < 200 mmHg
- ECMO < 24 hours in situ
- Gender-matched
- Age-matched
Key exclusion criteria (5 listed)
- BMI > 40
- Expected weaning of ECMO < 3 days (postoperative ECMO)
- Combustion
- Restrictive chest wall impairment
- Pregnancy
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 |
|---|---|---|
| Ultra-protective ventilator settings4-5 Breaths per minute; 14-16 cmH2O Positive endexpiratory pressure (PEEP) (adjust PEEP to 23 < Plateau pressure < 25 cmH2O); 23-25 cmH2O Plateau pressure (adjust to not exceed Tidal volume > 4 mL/kg Predicted body weight (PBW)); < 4mL/kg PBW Tidal volume; 1:5 Inspiration:Expiration (I:E) | Other | Intervention group |
| Standard ventilator settings12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure | Other | Control group |
Primary outcome
Ventilator free days
Time frame: Immediately after initiation of ECMO up to 28 days
Ventilator free days
Time from randomization to fulfillment of extubation criteria
Time frame: Immediately after initiation of ECMO up to 28 days
Time from randomization (initiation of ECMO) to fulfillment of the extubation criteria: * ARDS resolved * Temperature ≥ 36°C and ≤ 39°C * Low FiO2 (< 0.5) * PEEP (< 8 cmH2O) requirement * Able to initiate spontaneous breaths * Tidalvolume > 5 mL/kg or > 325 mL * Minute ventilation 5-6 L/min * PaO2/FiO2 > 200 mmHg * pH ≥ 7.25 * Ability to cough after deflating tube cuff * Respiratory rate 8-30/min * Hemodynamic stability
8 secondary outcomes
Total time of mechanical ventilation
Time frame: Start of mechanical ventilation up to 28 days
28 day mortality
Time frame: Immediately after initiation of ECMO up to 28 days
One year mortality
Time frame: Immediately after initiation of ECMO up to one year
Incidence of reintubation
Time frame: Immediately after initiation of ECMO up to 28 days
Length of ICU stay
Time frame: Immediately after initiation of ECMO
Evaluation of RAS, ACE, ACE2.
Time frame: 2 months
Evaluation of Cytokines in pg/ml
Time frame: 2 months
Evaluation of vitamin D status
Time frame: Length of ICU stay
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 17 Apr 2025.
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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.
Roman Ullrich, Ao.Univ.Prof. principal investigator
Department of Anesthesia and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-protective ventilator settings and Standard ventilator settings in people with ARDS and Acute Lung Injury, run by Medical University of Vienna at 1 site in Austria.
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 5 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 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 (time frame: Immediately after initiation of ECMO up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2025.