Respiratory Distress SyndromeVITALINCT00713713
Effect of Different Ventilatory Strategies on Cardiac Function in Patients With Acute Respiratory Failure
A study testing Mechanical ventilation with low and high tidal volume in people with Respiratory Distress Syndrome, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
Trial summary
Mechanical ventilation with low tidal volume (about 6 ml.kg-1) reduces mortality in ALI/ARDS patients respect to high tidal volume ventilation (about 12 ml.kg-1). This finding is usually explained by alveolar tidal overdistension associated to high tidal volume. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Mechanical ventilation with low and high tidal volume
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2008to Jun 2009
- 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
- diagnosis of ARDS/ALI
Who cannot join
- mean arterial pressure lower than 65 mmHg
- beginning or change of vasoactive agents infusion rate in the last 2 hours
Trial locations and contacts
1 site in 1 country.
Italy1 site
Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124
About this study
Official title: Hemodynamic Impact of Low and High Tidal Volume Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients
Mechanical ventilation with low tidal volume (about 6 ml.kg-1) reduces mortality in ALI/ARDS patients respect to high tidal volume ventilation (about 12 ml.kg-1).
This finding is usually explained by alveolar tidal overdistension associated to high tidal volume. Stretch-induced lung injury may trigger a cytokine-mediated inflammatory response. This may contribute to the development of systemic inflammatory response and multiple system organ failure and death.
Read more
High tidal volume strategies might affect organ function by pathways not mediated by inflammatory response.
It is well recognized the inverse relationship between tidal volume and cardiac output during mechanical ventilation. Nevertheless there are no clinical studies about cardiac output changes induced by low (6 ml.kg-1) and high tidal volume (12 ml.kg-1) in ALI/ARDS patients.
The study hypothesis is that high tidal volume ventilation reduces cardiac output in ALI/ARDS patients respect to low tidal volume strategy. Thereafter reduced hemodynamic impact could explain beneficial effect of low respect to high tidal volume ventilation.
If study hypothesis is confirmed, other studies should define the main cause of mortality reduction related to low tidal volume strategies and if appropriate hemodynamic monitoring and support should be required when low tidal volume strategies are harmful (i.e. traumatic brain injury).
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Mechanical ventilation with low and high tidal volume
- Keywords
- Respiratory Distress Syndrome, Adult, Tidal volume, cardiac output, Respiration, Artificial, Protective ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilation with low and high tidal volumeProcedure or surgery
Tidal volume of 6 or 12 ml.kg-1, calculated on ideal body weight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Two different tidal volumes (6 and 12 ml.kg-1 of ideal weight) are alternatively delivered to patients 30 minutes each one. The order of the two tidal volumes is randomized. Between the two study tidal volumes, patient returns for 30 minutes to the tidal volume used before the study recruitment. Receives: Procedure: Mechanical ventilation with low and high tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac index
Measured: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
Secondary outcomes (5)
oxygen delivery
Measured: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
oxygen consumption
Measured: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
mixed venous saturation
Measured: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
relationship between partitioned elastance (lung and chest wall) and cardiac index difference between ventilation with tidal volume 6 and 12 ml.kg-1
Measured: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
abdominal perfusion pressure (mean arterial pressure minus abdominal pressure)
Measured: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2009
- Study completionJun 2009
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 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe Natalini, MD, Principal investigator, Fondazione Poliambulanza Istituto Ospedaliero
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713713
- Sponsor's protocol ID
- FP-TIP-02
- Acronym
- VITALI
- Status last verified
- Jul 2009
- First submitted
- 9 Jul 2008
- Last updated
- 3 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Natalini G, Minelli C, Rosano A, Ferretti P, Militano CR, De Feo C, Bernardini A. Cardiac index and oxygen delivery during low and high tidal volume ventilation strategies in patients with acute respiratory distress syndrome: a crossover randomized clinical trial. Crit Care. 2013 Jul 23;17(4):R146. doi: 10.1186/cc12825.
PubMed 23880084
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Impact of Low and High Tidal Volume Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients
- ClinicalTrials.gov ID
- NCT00713713
- Acronym / sponsor ID
- VITALI / FP-TIP-02
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Respiratory Distress Syndrome, Adult, Tidal volume, cardiac output, Respiration, Artificial, Protective ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 Jul 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.
Mechanical ventilation with low tidal volume (about 6 ml.kg-1) reduces mortality in ALI/ARDS patients respect to high tidal volume ventilation (about 12 ml.kg-1).
This finding is usually explained by alveolar tidal overdistension associated to high tidal volume. Stretch-induced lung injury may trigger a cytokine-mediated inflammatory response. This may contribute to the development of systemic inflammatory response and multiple system organ failure and death.
High tidal volume strategies might affect organ function by pathways not mediated by inflammatory response.
It is well recognized the inverse relationship between tidal volume and cardiac output during mechanical ventilation. Nevertheless there are no clinical studies about cardiac output changes induced by low (6 ml.kg-1) and high tidal volume (12 ml.kg-1) in ALI/ARDS patients.
The study hypothesis is that high tidal volume ventilation reduces cardiac output in ALI/ARDS patients respect to low tidal volume strategy. Thereafter reduced hemodynamic impact could explain beneficial effect of low respect to high tidal volume ventilation.
If study hypothesis is confirmed, other studies should define the main cause of mortality reduction related to low tidal volume strategies and if appropriate hemodynamic monitoring and support should be required when low tidal volume strategies are harmful (i.e. traumatic brain injury).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Mechanical ventilation with low and high tidal volumeTwo different tidal volumes (6 and 12 ml.kg-1 of ideal weight) are alternatively delivered to patients 30 minutes each one. The order of the two tidal volumes is randomized. Between the two study tidal volumes, patient returns for 30 minutes to the tidal volume used before the study recruitment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of ARDS/ALI
Key exclusion criteria (2 listed)
- mean arterial pressure lower than 65 mmHg
- beginning or change of vasoactive agents infusion rate in the last 2 hours
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 |
|---|---|---|
| Mechanical ventilation with low and high tidal volumeTidal volume of 6 or 12 ml.kg-1, calculated on ideal body weight | Procedure or surgery | 1 |
Primary outcome
cardiac index
Time frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
5 secondary outcomes
oxygen delivery
Time frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
oxygen consumption
Time frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
mixed venous saturation
Time frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
relationship between partitioned elastance (lung and chest wall) and cardiac index difference between ventilation with tidal volume 6 and 12 ml.kg-1
Time frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
abdominal perfusion pressure (mean arterial pressure minus abdominal pressure)
Time frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
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 3 Aug 2009.
- Derived from this study: PubMed 23880084Natalini G, Minelli C, Rosano A, Ferretti P, Militano CR, De Feo C, Bernardini A. Cardiac index and oxygen delivery during low and high tidal volume ventilation strategies in patients with acute respiratory distress syndrome: a crossover randomized clinical trial. Crit Care. 2013 Jul 23;17(4):R146. doi: 10.1186/cc12825.
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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.
Giuseppe Natalini, MD principal investigator
Fondazione Poliambulanza Istituto Ospedaliero
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ventilation with low and high tidal volume in people with Respiratory Distress Syndrome, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
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 1 inclusion and 2 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 3 Aug 2009. 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 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?
cardiac index (time frame: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1). 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 NCT00713713, 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 3 Aug 2009.