Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)

NATerminatedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

June 30, 2020

Study Completion Date

June 30, 2020

Conditions
ARDS
Interventions
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).~* 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"

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).~* 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."

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.

Trial Locations (1)

08208

Hospital de Sabadell, CSUPT, Sabadell

Sponsors
All Listed Sponsors
lead

Corporacion Parc Tauli

OTHER