NCT02070666

Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)

Preventive Strategies in Acute Respiratory Distress Syndrome

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• ARDS

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2014-02-25
• Last updated: 2020-06-19

Locations

1 site across 1 country: Spain