Preventive Strategies in Acute Respiratory Distress Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ARDS
- Sponsor
- Corporacion Parc Tauli
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- ARDS development
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Antonio Artigas Raventós
Director of Critical Care Arrea
Corporacion Parc Tauli
Eligibility 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.
Outcomes
Primary Outcomes
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 Outcomes
- Mortality(90 days)
- Ventilator-free days(28 days after admission)
- Pneumonia(7 days)
- Dead space(7 days)
- Length of stay(participants will be followed for the duration of ICU (Intensive Care Unit) and hospital stay, an expected average of 4 weeks)
- Atelectasis(7 days)