Prospective, Randomized, Controlled Trial Assessing the Effects of a Driving-pressure Limiting STrAtegy for Patients With Acute Respiratory Distress Syndrome Due to coMmunIty-acquired pNeumoniA (STAMINA Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Community-acquired Pneumonia
- Sponsor
- Hospital do Coracao
- Enrollment
- 214
- Locations
- 6
- Primary Endpoint
- Mechanical ventilation free days
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Mechanical ventilation free days
Time Frame: 28 days
Number of days patient remains independent of mechanical ventilation
Secondary Outcomes
- Need for rescue therapies for refractory hypoxemia(28 days)
- Intensive Care Unit Mortality(90 days)
- Occurrence of barotrauma(28 days)
- Hospital Mortality(90 days)