Acute Respiratory Distress Syndrome, Community-acquired Pneumonia
Conditions
Keywords
mechanical ventilation, positive end-expiratory pressure, community-acquired pneumonia
Brief summary
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
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.
Interventions
PROCEDUREPositive end-expiratory pressure titration with driving pressure control
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.
PROCEDUREARDSNet ventilatory strategy
Positive end-expiratory pressure will be set according to fixed inspired oxygen fraction values.
Sponsors
Brazilian Research In Intensive Care Network
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical ventilation free days | 28 days | Number of days patient remains independent of mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Mortality | 90 days | Whether the patient perished or not during hospitalization |
| Intensive Care Unit Mortality | 90 days | Whether the patient perished or not during intensive care unit stay, truncated at 28 days |
| Need for rescue therapies for refractory hypoxemia | 28 days | Need for extracorporeal membrane oxygenation, alveolar recruitment maneuver, or inhaled nitroux oxide, truncated at 28 days |
| Occurrence of barotrauma | 28 days | Occurrence of either subcutaneous emphysema, pneumothorax or pneumatocele, truncated at 28 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Driving Pressure during mechanical ventilation | 3 days | Driving pressured, measured once daily and defined by airway plateau pressure minus positive end-expiratory pressure |
| Intensive Care Unit Free Days | 28 days | Number of days the patient spend alive and out of the intensive care unit |
| Ventilatory Rate | 3 days | Ventilatory Rate, measured daily, defined as minute ventilation (in liters) multiplied by arterial partial pressure of oxygen, divided by 37.5 multiplied by patient weight (in kilograms) multiplied by 100 |
| Oxygenation parameters (oxygenation index and fraction of arterial pressure of oxygen over inspired oxygen fraction) | 3 days | Measurements of oxygenation in the first 3 days after enrollment (ratio between arterial partial pressure of oxygen over inspired fraction of oxygen, and oxygenation index, defined by mean airway pressure multiplied by fraction of inspired oxygen over arterial partial pressure of oxygen. |
Countries
Brazil
Outcome results
None listed