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Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS) (EPALI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02070666
Recruitment Status : Unknown
Verified July 2016 by Antonio Artigas Raventós, Corporacion Parc Tauli.
Recruitment status was:  Recruiting
First Posted : February 25, 2014
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
Antonio Artigas Raventós, Corporacion Parc Tauli

Tracking Information
First Submitted Date  ICMJE February 19, 2014
First Posted Date  ICMJE February 25, 2014
Last Update Posted Date August 1, 2016
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2014)
ARDS development [ Time Frame: 7 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02070666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2014)
  • Mortality [ Time Frame: 90 days ]
    In-hospital mortality, 28-day mortality and 90-day mortality
  • Ventilator-free days [ Time Frame: 28 days after admission ]
    From 1 to 28 days over 28 days in a month
  • Dead space [ Time Frame: 7 days ]
    Volumetric capnography
  • Length of stay [ Time Frame: participants will be followed for the duration of ICU (Intensive Care Unit) and hospital stay, an expected average of 4 weeks ]
    ICU stay and hospital stay
  • Pneumonia [ Time Frame: 7 days ]
    Incidence of pneumonia
  • Atelectasis [ Time Frame: 7 days ]
    Incidence of atelectasis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)
Official Title  ICMJE Preventive Strategies in Acute Respiratory Distress Syndrome
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE ARDS
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Protective ventilation arm
    • Low tidal volumes (from 4 to 6 milliliters(mL)/kilogram (kg) of predicted body weight (PBW)
    • Plateau pressure less than 25 centimeter of water (cmH2O)
    • Minimum PEEP of 5 cmH2O.
    Interventions:
    • Behavioral: Protective mechanical ventilation
    • Other: Dead space
  • Active Comparator: Control group

    Traditional-sized tidal volumes (from 8 to 10 mL/kg PBW)

    • Plateau pressure less than 25 cmH2O
    • Minimum PEEP of 5 cmH2O.
    Interventions:
    • Behavioral: Control group
    • Other: Dead space
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 21, 2014)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients within 12 hours after start of invasive mechanical ventilation (MV) and admitted to participating ICU (it is recommended an inclusion as soon as possible during the first 3 hours).
  • LIPS > 4 points.
  • Absence of mild, moderate and severe ARDS criteria (Berlin definition).
  • Older than 18 year-old.
  • Signed informed consent

Exclusion Criteria:

  • Bilateral pulmonary infiltrates in chest X-ray at admission.
  • Mechanical ventilation > 12 hours.
  • Previous pneumonectomy or lobectomy.
  • Severe cranial trauma (Glasgow Coma Scale<9) or cranial hypertension.
  • Severe chronic pulmonary disease (GOLD IV).
  • Admission from other hospital under MV.
  • Limitation of therapeutic effort.
  • Pregnancy.
  • Acute pulmonary embolism.
  • Participation in other interventional trials.
  • Previous randomized in the proposed trial.
  • Absence of informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02070666
Other Study ID Numbers  ICMJE EPALI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antonio Artigas Raventós, Corporacion Parc Tauli
Study Sponsor  ICMJE Corporacion Parc Tauli
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Corporacion Parc Tauli
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP