Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS) (EPALI)
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ClinicalTrials.gov Identifier: NCT02070666 |
Recruitment Status :
Terminated
(Low recruitment and published data with no benefit)
First Posted : February 25, 2014
Last Update Posted : June 19, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
ARDS | Behavioral: Protective mechanical ventilation Behavioral: Control group Other: Dead space | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 98 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Preventive Strategies in Acute Respiratory Distress Syndrome |
Study Start Date : | May 2014 |
Actual Primary Completion Date : | June 2020 |
Actual Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
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Experimental: Protective ventilation arm
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Behavioral: Protective mechanical ventilation
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).
Other: Dead space 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. |
Active Comparator: Control group
Traditional-sized tidal volumes (from 8 to 10 mL/kg PBW)
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Behavioral: Control group
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).
Other: Dead space 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. |
- 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.
- Mortality [ Time Frame: 90 days ]In-hospital mortality, 28-day mortality and 90-day mortality
- Ventilator-free days [ Time Frame: 28 days after admission ]From 1 to 28 days over 28 days in a month
- Dead space [ Time Frame: 7 days ]Volumetric capnography
- 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 ]ICU stay and hospital stay
- Pneumonia [ Time Frame: 7 days ]Incidence of pneumonia
- Atelectasis [ Time Frame: 7 days ]Incidence of atelectasis

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Limitation of therapeutic effort.
- Pregnancy.
- Acute pulmonary embolism.
- Participation in other interventional trials.
- Previous randomized in the proposed trial.
- Absence of informed consent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070666
Spain | |
Hospital de Sabadell, CSUPT | |
Sabadell, Barcelona, Spain, 08208 |
Responsible Party: | Antonio Artigas Raventós, Director of Critical Care Arrea, Corporacion Parc Tauli |
ClinicalTrials.gov Identifier: | NCT02070666 |
Other Study ID Numbers: |
EPALI |
First Posted: | February 25, 2014 Key Record Dates |
Last Update Posted: | June 19, 2020 |
Last Verified: | June 2020 |
ARDS Prevention Protective mechanical ventilation low tidal volumes |
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |