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Low recruitment and published data with no benefit
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protective ventilation arm | Experimental |
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| Control group | Active Comparator | Traditional-sized tidal volumes (from 8 to 10 mL/kg PBW)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protective mechanical ventilation | Behavioral | 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).
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | In-hospital mortality, 28-day mortality and 90-day mortality | 90 days |
| Ventilator-free days | From 1 to 28 days over 28 days in a month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Sabadell, CSUPT | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37351068 | Derived | 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. |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D012126 | Respiratory Dead Space |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Behavioral | 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).
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| Dead space | Other | 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. |
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| 28 days after admission |
| Dead space | Volumetric capnography | 7 days |
| Length of stay | ICU stay and hospital stay | 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 | 7 days |
| Atelectasis | Incidence of atelectasis | 7 days |
| D008722 | Methods |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |