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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
98
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
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.
Hospital de Sabadell, CSUPT
Sabadell, Barcelona, Spain
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.
Time frame: 7 days
Mortality
In-hospital mortality, 28-day mortality and 90-day mortality
Time frame: 90 days
Ventilator-free days
From 1 to 28 days over 28 days in a month
Time frame: 28 days after admission
Dead space
Volumetric capnography
Time frame: 7 days
Length of stay
ICU stay and hospital 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
Incidence of pneumonia
Time frame: 7 days
Atelectasis
Incidence of atelectasis
Time frame: 7 days
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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.