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

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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

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.


Condition or disease Intervention/treatment Phase
ARDS Behavioral: Protective mechanical ventilation Behavioral: Control group Other: Dead space Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventive Strategies in Acute Respiratory Distress Syndrome
Study Start Date : May 2014
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : January 2018


Arm Intervention/treatment
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.
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

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.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 90 days ]
    In-hospital mortality, 28-day mortality and 90-day mortality

  2. Ventilator-free days [ Time Frame: 28 days after admission ]
    From 1 to 28 days over 28 days in a month

  3. Dead space [ Time Frame: 7 days ]
    Volumetric capnography

  4. 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

  5. Pneumonia [ Time Frame: 7 days ]
    Incidence of pneumonia

  6. Atelectasis [ Time Frame: 7 days ]
    Incidence of atelectasis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070666


Contacts
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Contact: Candelaria de Haro, MD +34937231010 ext 21158 cdeharo@tauli.cat
Contact: Gisela Gili, RN +3493721010 ext 21159 ggilis@tauli.cat

Locations
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Spain
Hospital de Sabadell, CSUPT Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Candelaria de Haro, MD    0034937231010 ext 21158    cdeharo@tauli.cat   
Principal Investigator: Candelaria de Haro, MD         
Sponsors and Collaborators
Corporacion Parc Tauli

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Responsible Party: Antonio Artigas Raventós, Director of Critical Care Arrea, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02070666    
Other Study ID Numbers: EPALI
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016
Keywords provided by Antonio Artigas Raventós, Corporacion Parc Tauli:
ARDS
Prevention
Protective mechanical ventilation
low tidal volumes
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury