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Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)

NCT02070666 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2020-06-19

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02070666 on ClinicalTrials.gov