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

• ClinicalTrials.gov Identifier: NCT02070666
• Recruitment Status: Unknown
• First Posted: February 25, 2014
• Last Update Posted: August 1, 2016
• Sponsor: Corporacion Parc Tauli
• Information provided by (Responsible Party): Antonio Artigas Raventós, Corporacion Parc Tauli

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Candelaria de Haro, MD; +34937231010 ext 21158; cdeharo@tauli.cat

Contact: Gisela Gili, RN; +3493721010 ext 21159; ggilis@tauli.cat

Locations

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

More Information

• 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
• 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:

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