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

Corporacion Parc Tauli

Status: Terminated

Conditions: ARDS

Treatments: Other: Dead space; Behavioral: Control group; Behavioral: Protective mechanical ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02070666

EPALI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Protective ventilation arm

Experimental group

Description:

* 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.

Treatment:

Behavioral: Protective mechanical ventilation

Other: Dead space

Control group

Active Comparator group

Description:

Traditional-sized tidal volumes (from 8 to 10 mL/kg PBW) * Plateau pressure less than 25 cmH2O * Minimum PEEP of 5 cmH2O.

Treatment:

Other: Dead space

Behavioral: Control group