ARDSEPALINCT02070666
Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)
A study testing Protective mechanical ventilation and Dead space in people with ARDS, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The investigators hypothesis is that patients at risk of ARDS, detected by LIPS (Lung Injury Prediction Score), under mechanical ventilation could benefit from a protective ventilatory strategy (used in ARDS treatment) in order to avoid or decrease the ARDS development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- Protective mechanical ventilation and Dead space
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Jun 2020
- 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
- Patients within 12 hours after start of invasive mechanical ventilation (MV) and admitted to participating ICU (it is recommended an inclusion as soon as possible during the first 3 hours).
- LIPS > 4 points.
- Absence of mild, moderate and severe ARDS criteria (Berlin definition).
- Older than 18 year-old.
- Signed informed consent
Who cannot join
- Bilateral pulmonary infiltrates in chest X-ray at admission.
- Mechanical ventilation > 12 hours.
- Previous pneumonectomy or lobectomy.
- Severe cranial trauma (Glasgow Coma Scale<9) or cranial hypertension.
- Severe chronic pulmonary disease (GOLD IV).
- Admission from other hospital under MV.
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- Limitation of therapeutic effort.
- Pregnancy.
- Acute pulmonary embolism.
- Participation in other interventional trials.
- Previous randomized in the proposed trial.
- Absence of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventive Strategies in Acute Respiratory Distress Syndrome
The investigators hypothesis is that patients at risk of ARDS, detected by LIPS (Lung Injury Prediction Score), under mechanical ventilation could benefit from a protective ventilatory strategy (used in ARDS treatment) in order to avoid or decrease the ARDS development. This would lead to a decrease in incidence, mortality and health care costs associated to this syndrome.
This study will help to confirm the current evidence about low tidal volumes, evaluating adverse events of this strategy.
Read the detailed description
The main objective is to evaluate the effect of a protective ventilatory strategy by using lower tidal volumes compared to the use of traditionally volumes in ARDS development.
- Conditions
- ARDS
- Being tested
- Protective mechanical ventilation, Control group, Dead space
- Keywords
- ARDS, Prevention, Protective mechanical ventilation, low tidal volumes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective mechanical ventilationBehavioural
Ventilation mode: volume control, pressure control, dual modes (It is allowed to change to a spontaneous mode; a minimum of 5 cmH2O level of support should be used; in case the resulting tidal volume exceeds 6 mL/kg PBW this is accepted. This is not a reason to use more sedation and/or muscle relaxants, or to switch the ventilator to a controlled mode of ventilation).
- Tidal volume: 6 mL/Kg PBW, decreasing 1 mL/kg PBW each step if necessary (steps of 5 minutes), to maintain plateau pressure < 25 cmH2O until a minimum tidal volume of 4 mL/Kg PBW, unless the patient suffers from severe dyspnea or unacceptable acidosis.
- Fraction of inspired oxygen inspired oxygen fraction (FiO2) > 0.21 to maintain oxygen saturation 90-92%.
- PEEP ≥ 5 cmH2O, and optimized to maintain Oxygen saturation (SpO2) 90-92% (left to the discretion of the attending physician).
- Plateau pressure ≤ 25 cmH2O
Control groupBehavioural
Ventilation mode: volume control, pressure control, dual modes (It is allowed to change to a spontaneous mode, with the level of support adjusted to reach tidal volumes minimum of 8 mL/kg predicted body weight PBW; if it is not possible, the data collection should be continue and an intention-to-treat analysis will be done).
- Tidal volume: minimum 8 mL/kg PBW. It is possible to increase until 10 mL/kg PBW unless plateau pressure increases above 25 cmH2O.
- FiO2 > 0.21 to maintain oxygen saturation 90-92%.
- PEEP ≥ 5 cmH2O, and optimized to maintain SpO2 90-92% (left to the discretion of the attending physician).
- Plateau pressure ≤ 25 cm H2O.
Dead spaceOther
Volumetric capnography will be used. Dead space (Vd/Vt) measurements will be taken at baseline and daily after initiation of mechanical ventilation. Nursing and respiratory care activities (including changes to ventilator settings) will be suspended for at least 5 minutes prior to all Vd/Vt measurements.
| Study group | Role | What they receive |
|---|---|---|
| Protective ventilation arm | Experimental | * Low tidal volumes (from 4 to 6 milliliters(mL)/kilogram (kg) of predicted body weight (PBW)
* Plateau pressure less than 25 centimeter of water (cmH2O)
* Minimum PEEP of 5 cmH2O. Receives: Behavioral: Protective mechanical ventilation; Other: Dead space |
| Control group | Active comparator | Traditional-sized tidal volumes (from 8 to 10 mL/kg PBW)
* Plateau pressure less than 25 cmH2O
* Minimum PEEP of 5 cmH2O. Receives: Behavioral: Control group; Other: Dead space |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARDS development
To determine the effect of a protective mechanical ventilation strategy using lower tidal volumes as compared to mechanical ventilation using traditionally-sized tidal volumes on development of ARDS.
Measured: 7 days
Secondary outcomes (6)
Mortality
In-hospital mortality, 28-day mortality and 90-day mortality
Measured: 90 days
Ventilator-free days
From 1 to 28 days over 28 days in a month
Measured: 28 days after admission
Dead space
Volumetric capnography
Measured: 7 days
Length of stay
ICU stay and hospital stay
Measured: participants will be followed for the duration of ICU (Intensive Care Unit) and hospital stay, an expected average of 4 weeks
Pneumonia
Incidence of pneumonia
Measured: 7 days
Atelectasis
Incidence of atelectasis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2020
- Study completionJun 2020
Why it stopped: Low recruitment and published data with no benefit
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Artigas Raventós, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070666
- Sponsor's protocol ID
- EPALI
- Acronym
- EPALI
- Status last verified
- Jun 2020
- First submitted
- 19 Feb 2014
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Haro C, Neto AS, Goma G, Gonzalez ME, Ortega A, Forteza C, Frutos-Vivar F, Garcia R, Simonis FD, Gordo-Vidal F, Suarez D, Schultz MJ, Artigas A. Effect of a low versus intermediate tidal volume strategy on pulmonary complications in patients at risk of acute respiratory distress syndrome-a randomized clinical trial. Front Med (Lausanne). 2023 Jun 7;10:1172434. doi: 10.3389/fmed.2023.1172434. eCollection 2023.
PubMed 37351068
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Strategies in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02070666
- Acronym / sponsor ID
- EPALI / EPALI
- Conditions
- ARDS
- Keywords
- ARDS, Prevention, Protective mechanical ventilation, low tidal volumes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment and published data with no benefit
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 25 Feb 2014 (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.
The investigators hypothesis is that patients at risk of ARDS, detected by LIPS (Lung Injury Prediction Score), under mechanical ventilation could benefit from a protective ventilatory strategy (used in ARDS treatment) in order to avoid or decrease the ARDS development. This would lead to a decrease in incidence, mortality and health care costs associated to this syndrome.
This study will help to confirm the current evidence about low tidal volumes, evaluating adverse events of this strategy.
Detailed description
The main objective is to evaluate the effect of a protective ventilatory strategy by using lower tidal volumes compared to the use of traditionally volumes in ARDS development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protective ventilation arm | Experimental | Behavioral: Protective mechanical ventilation, Other: Dead space* Low tidal volumes (from 4 to 6 milliliters(mL)/kilogram (kg) of predicted body weight (PBW) * Plateau pressure less than 25 centimeter of water (cmH2O) * Minimum PEEP of 5 cmH2O. |
| Control group | Active comparator | Behavioral: Control group, Other: Dead spaceTraditional-sized tidal volumes (from 8 to 10 mL/kg PBW) * Plateau pressure less than 25 cmH2O * Minimum PEEP of 5 cmH2O. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients within 12 hours after start of invasive mechanical ventilation (MV) and admitted to participating ICU (it is recommended an inclusion as soon as possible during the first 3 hours).
- LIPS > 4 points.
- Absence of mild, moderate and severe ARDS criteria (Berlin definition).
- Older than 18 year-old.
- Signed informed consent
Key exclusion criteria (12 listed)
- Bilateral pulmonary infiltrates in chest X-ray at admission.
- Mechanical ventilation > 12 hours.
- Previous pneumonectomy or lobectomy.
- Severe cranial trauma (Glasgow Coma Scale<9) or cranial hypertension.
- Severe chronic pulmonary disease (GOLD IV).
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 |
|---|---|---|
| Protective mechanical ventilationVentilation mode: volume control, pressure control, dual modes (It is allowed to change to a spontaneous mode; a minimum of 5 cmH2O level of support should be used; in case the resulting tidal volume exceeds 6 mL/kg PBW this is accepted. This is not a reason to use more sedation and/or muscle relaxants, or to switch the ventilator to a controlled mode of ventilation). * Tidal volume: 6 mL/Kg PBW, decreasing 1 mL/kg PBW each step if necessary (steps of 5 minutes), to maintain plateau pressure < 25 cmH2O until a minimum tidal volume of 4 mL/Kg PBW, unless the patient suffers from severe dyspnea or unacceptable acidosis. * Fraction of inspired oxygen inspired oxygen fraction (FiO2) > 0.21 to maintain oxygen saturation 90-92%. * PEEP ≥ 5 cmH2O, and optimized to maintain Oxygen saturation (SpO2) 90-92% (left to the discretion of the attending physician). * Plateau pressure ≤ 25 cmH2O | Behavioural | Protective ventilation arm |
| Control groupVentilation mode: volume control, pressure control, dual modes (It is allowed to change to a spontaneous mode, with the level of support adjusted to reach tidal volumes minimum of 8 mL/kg predicted body weight PBW; if it is not possible, the data collection should be continue and an intention-to-treat analysis will be done). * Tidal volume: minimum 8 mL/kg PBW. It is possible to increase until 10 mL/kg PBW unless plateau pressure increases above 25 cmH2O. · FiO2 > 0.21 to maintain oxygen saturation 90-92%. * PEEP ≥ 5 cmH2O, and optimized to maintain SpO2 90-92% (left to the discretion of the attending physician). * Plateau pressure ≤ 25 cm H2O. | Behavioural | Control group |
| Dead spaceVolumetric capnography will be used. Dead space (Vd/Vt) measurements will be taken at baseline and daily after initiation of mechanical ventilation. Nursing and respiratory care activities (including changes to ventilator settings) will be suspended for at least 5 minutes prior to all Vd/Vt measurements. | Other | Control group, Protective ventilation arm |
Primary outcome
ARDS development
Time frame: 7 days
To determine the effect of a protective mechanical ventilation strategy using lower tidal volumes as compared to mechanical ventilation using traditionally-sized tidal volumes on development of ARDS.
6 secondary outcomes
Mortality
Time frame: 90 days
Ventilator-free days
Time frame: 28 days after admission
Dead space
Time frame: 7 days
Length of stay
Time frame: participants will be followed for the duration of ICU (Intensive Care Unit) and hospital stay, an expected average of 4 weeks
Pneumonia
Time frame: 7 days
Atelectasis
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Low recruitment and published data with no benefit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Derived from this study: PubMed 37351068de Haro C, Neto AS, Goma G, Gonzalez ME, Ortega A, Forteza C, Frutos-Vivar F, Garcia R, Simonis FD, Gordo-Vidal F, Suarez D, Schultz MJ, Artigas A. Effect of a low versus intermediate tidal volume strategy on pulmonary complications in patients at risk of acute respiratory distress syndrome-a randomized clinical trial. Front Med (Lausanne). 2023 Jun 7;10:1172434. doi: 10.3389/fmed.2023.1172434. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protective mechanical ventilation and Dead space in people with ARDS, run by Corporacion Parc Tauli at 1 site in Spain.
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 12 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 19 Jun 2020. 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 Spain. 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: Low recruitment and published data with no benefit). 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?
ARDS development (time frame: 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 NCT02070666, 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 19 Jun 2020.