Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia

Study Overview
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Brief Summary
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Randomized Controlled Trial Comparing Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia. The control strategy will be based on ARDSNet approach. The intervention group will receive a different ventilatory strategy based on positive end-expiratory pressure tailored according to compliance and limited driving pressure.

Detailed Description
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There is no consensus on the optimal ventilatory management of patients with community-acquired pneumonia that require mechanical ventilation and have acute respiratory distress syndrome. The traditional ventilatory approach (ARDSNet) is based on a fixed table for both end respiratory positive end-expiratory pressure according to inspired oxygen fraction. Alternatively, a strategy that tailors positive end-expiratory pressure according to compliance and limits driving pressure may be beneficial, but evidence is lacking. We will perform an open label randomized controlled trial comparing both strategies.

Official Title
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Randomized Controlled Trial Comparing Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia: STAMINA

Conditions
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Community-acquired Pneumonia, Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Procedure: Positive end-expiratory pressure titration with driving pressure control
* Procedure: ARDSNet ventilatory strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with community acquired pneumonia requiring invasive mechanical ventilation Bilateral pulmonary infiltrates on chest imaging not fully explained by fluid overload in the opinion of the attending physician One of the criteria below: Oxygen inspired fraction above 50% with a positive end-expiratory pressure of at least 8 cmH2O to main peripheral oxygen saturation above 93%, OR Arterial partial pressure of oxygen divided by inspired fraction of oxygen lower than 200 with PEEP values of at least 5 cmH2O Exclusion Criteria: Patients with inclusion criteria for more than 36 hours Refusal of the patient´s legal representative Acute neurologic disease (stroke, brain trauma, or any disease that may cause intracranial hypertension) Patients with current airway fistula or barotrauma Patients on chronic home use of oxygen due to underlying lung disease Patients younger than 18 years Patients not on full code status

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARDSNet strategy<br>Patients will receive a mechanical ventilation strategy based on fixed values of positive end-expiratory pressure according to inspired fraction of oxygen. Plateau pressure will be limited at 30 cmH2O. This strategy will be mantained and monitored for 3 days, unless the patient dies or is extubated before. This arm is similar to the ARMA (Ventilation with Lower Tidal Volumes as Compared with Traditional Tidal Volumes for Acute Lung Injury and the Acute Respiratory Distress Syndrome) trial. | Procedure: ARDSNet ventilatory strategy<br>* Positive end-expiratory pressure will be set according to fixed inspired oxygen fraction values.<br>|
| Experimental: STAMINA strategy<br>Patients will receive a mechanical ventilation strategy based on positive end-expiratory pressure tailored to achieve the optimal respiratory system compliance and to have driving pressure limited to 14 cmH2O. Plateau pressure will be limited at 30 cmH2O. This strategy will be mantained and monitored for 3 days, unless the patient dies or is extubated before. | Procedure: Positive end-expiratory pressure titration with driving pressure control<br>* Positive end-expiratory pressure will be tailored during a decremental maneuver (without a formal alveolar recruitment maneuver). The best positive end-expiratory pressure will be defined as the one associated with the higher respiratory system compliance, up to 20 cmH2O. Plateau pressure limit will be 30 cmH2O. If driving pressure remains elevated after optimal PEEP setting, tidal volume will be reduced to keep driving pressure below 14 cmH2O.<br>* Other names: STAMINA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation free days | Number of days patient remains independent of mechanical ventilation | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality | Whether the patient perished or not during hospitalization | 90 days | 
| Intensive Care Unit Mortality | Whether the patient perished or not during intensive care unit stay, truncated at 28 days | 90 days | 
| Need for rescue therapies for refractory hypoxemia | Need for extracorporeal membrane oxygenation, alveolar recruitment maneuver, or inhaled nitroux oxide, truncated at 28 days | 28 days | 
| Occurrence of barotrauma | Occurrence of either subcutaneous emphysema, pneumothorax or pneumatocele, truncated at 28 days | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, positive end-expiratory pressure, community-acquired pneumonia