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

Hospital do Coracao

Status: Terminated

Conditions: Community-acquired Pneumonia; Acute Respiratory Distress Syndrome

Treatments: Procedure: Positive end-expiratory pressure titration with driving pressure control; Procedure: ARDSNet ventilatory strategy

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04972318

stamina_trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

214 participants in 2 patient groups

ARDSNet strategy

Active Comparator group

Description:

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.

Treatment:

Procedure: ARDSNet ventilatory strategy

STAMINA strategy

Experimental group

Description:

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.

Treatment:

Procedure: Positive end-expiratory pressure titration with driving pressure control