Acute Lung InjuryEVANCT00786292
Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury
A study testing Assisted mechanical ventilation in people with Acute Lung Injury, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to improve the respiratory function in experimental acute lung injury (ALI). We aimed at comparing the effects of noisy PSV with traditional PSV on the respiratory function of patients suffering from ALI. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- Assisted mechanical ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Sep 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 to 75 yrs
- 150 mmHg < PaO2/FIO2 < 300 mmHg
- mechanical ventilation with PSV or BIPAP
- less than 15 days of mechanical ventilation
- at least 20% of minute ventilation originated from spontaneous breathing
Who cannot join
- BMI > 35
- esophageal disease
- neuromuscular disease
- instable thorax
- pneumothorax
- head trauma
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- brain injury
- increased intracranial pressure
- agitation
- increased need for vasoactive drugs
- chronic lung disease
- acute coronary disease
- participation in another clinical trial within the last 4 weeks at enrollment
- Interruption criteria:
- acute change of mental status
- SaO2 < 92%
- pHa < 7.30
- respiratory rate > 30 or < 6 /min
- dyspnea
- diaphragm/thorax antagonism
- diaphoresis
- abnormal use of respiratory muscles
- increase of the heart rate above 120% of baseline or absolute value < 60 or > 130 /min
- mean arterial pressure above 120% of baseline or absolute value < 70 or > 110 mmHg
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Clinic Carl Gustav Carus, Technical University Dresden
Dresden, 01307
About this study
Official title: Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury (EVA-Trial)
Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to improve the respiratory function in experimental acute lung injury (ALI). We aimed at comparing the effects of noisy PSV with traditional PSV on the respiratory function of patients suffering from ALI.
- Conditions
- Acute Lung Injury
- Being tested
- Assisted mechanical ventilation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted mechanical ventilationOther
Patients will be mechanically ventilated with noisy PSV and PSV in random sequence
| Study group | Role | What they receive |
|---|---|---|
| Noisy PSV | Other | Assisted mechanical ventilation with noisy PSV Receives: Other: Assisted mechanical ventilation |
| PSV | Other | Assisted mechanical ventilation with PSV Receives: Other: Assisted mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on the arterial oxygenation
Secondary outcomes (2)
Effect on the work of breathing
Effect on PaCO2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startJul 2009
- Primary completionSep 2012
- Study completionSep 2012
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 Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Marcelo Gama de Abreu, Technische Universität Dresden
- Investigators
- Marcelo Gama de Abreu, MD, PhD, Principal investigator, Department of Anesthesiology, University Clinic Carl Gustav Carus, Technical University Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786292
- Sponsor's protocol ID
- EK276112007
- Acronym
- EVA
- Status last verified
- Jul 2009
- First submitted
- 5 Nov 2008
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Spieth PM, Guldner A, Huhle R, Beda A, Bluth T, Schreiter D, Ragaller M, Gottschlich B, Kiss T, Jaber S, Pelosi P, Koch T, Gama de Abreu M. Short-term effects of noisy pressure support ventilation in patients with acute hypoxemic respiratory failure. Crit Care. 2013 Oct 31;17(5):R261. doi: 10.1186/cc13091.
PubMed 24172538
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury (EVA-Trial)
- ClinicalTrials.gov ID
- NCT00786292
- Acronym / sponsor ID
- EVA / EK276112007
- Conditions
- Acute Lung Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Nov 2008 (estimated)
- 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.
Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to improve the respiratory function in experimental acute lung injury (ALI). We aimed at comparing the effects of noisy PSV with traditional PSV on the respiratory function of patients suffering from ALI.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noisy PSV | Other | Other: Assisted mechanical ventilationAssisted mechanical ventilation with noisy PSV |
| PSV | Other | Other: Assisted mechanical ventilationAssisted mechanical ventilation with PSV |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 to 75 yrs
- 150 mmHg < PaO2/FIO2 < 300 mmHg
- mechanical ventilation with PSV or BIPAP
- less than 15 days of mechanical ventilation
- at least 20% of minute ventilation originated from spontaneous breathing
Key exclusion criteria (24 listed)
- BMI > 35
- esophageal disease
- neuromuscular disease
- instable thorax
- pneumothorax
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 |
|---|---|---|
| Assisted mechanical ventilationPatients will be mechanically ventilated with noisy PSV and PSV in random sequence | Other | Noisy PSV, PSV |
Primary outcome
Effect on the arterial oxygenation
2 secondary outcomes
Effect on the work of breathing
Effect on PaCO2
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 5 Sep 2012.
- Derived from this study: PubMed 24172538Spieth PM, Guldner A, Huhle R, Beda A, Bluth T, Schreiter D, Ragaller M, Gottschlich B, Kiss T, Jaber S, Pelosi P, Koch T, Gama de Abreu M. Short-term effects of noisy pressure support ventilation in patients with acute hypoxemic respiratory failure. Crit Care. 2013 Oct 31;17(5):R261. doi: 10.1186/cc13091.
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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.
Marcelo Gama de Abreu, MD, PhD principal investigator
Department of Anesthesiology, University Clinic Carl Gustav Carus, Technical University Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted mechanical ventilation in people with Acute Lung Injury, run by Technische Universität Dresden at 1 site in Germany.
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 5 inclusion and 24 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 5 Sep 2012. 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 Germany. 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?
Effect on the arterial oxygenation. 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 NCT00786292, 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 Sep 2012.