Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)

Not Applicable

Terminated

• Conditions: ARDS
• Interventions: Behavioral: Protective mechanical ventilation; Behavioral: Control group; Other: Dead space

• Registration Number: NCT02070666
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-25
• Study Start: 2014-05
• Status Verified: 2020-06
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-06-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protective ventilation arm	Protective mechanical ventilation	* 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.
Protective ventilation arm	Dead space	* 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.
Control group	Dead space	Traditional-sized tidal volumes (from 8 to 10 mL/kg PBW) * Plateau pressure less than 25 cmH2O * Minimum PEEP of 5 cmH2O.
Control group	Control group	Traditional-sized tidal volumes (from 8 to 10 mL/kg PBW) * Plateau pressure less than 25 cmH2O * Minimum PEEP of 5 cmH2O.

Primary Outcome Measures

Name	Time	Method
ARDS development	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

Name	Time	Method
Mortality	90 days	In-hospital mortality, 28-day mortality and 90-day mortality
Ventilator-free days	28 days after admission	From 1 to 28 days over 28 days in a month
Pneumonia	7 days	Incidence of pneumonia
Dead space	7 days	Volumetric capnography
Length of stay	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
Atelectasis	7 days	Incidence of atelectasis

Trial Locations

Locations (1)

Hospital de Sabadell, CSUPT; 🇪🇸 Sabadell, Barcelona, Spain