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

Not Applicable

Terminated

• Conditions: Acute Respiratory Distress Syndrome; Community-acquired Pneumonia
• Interventions: Procedure: ARDSNet ventilatory strategy; Procedure: Positive end-expiratory pressure titration with driving pressure control

• Registration Number: NCT04972318
• Lead Sponsor: Hospital do Coracao

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.

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-22
• Study Start: 2021-09-04
• Status Verified: 2023-06
• Primary Completion: 2023-09-09
• Study Completion: 2023-09-21
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARDSNet strategy	ARDSNet ventilatory strategy	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.
STAMINA strategy	Positive end-expiratory pressure titration with driving pressure control	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.

Primary Outcome Measures

Name	Time	Method
Mechanical ventilation free days	28 days	Number of days patient remains independent of mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
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
Intensive Care Unit Mortality	90 days	Whether the patient perished or not during intensive care unit stay, truncated at 28 days
Occurrence of barotrauma	28 days	Occurrence of either subcutaneous emphysema, pneumothorax or pneumatocele, truncated at 28 days
Hospital Mortality	90 days	Whether the patient perished or not during hospitalization

Trial Locations

Locations (6)

Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina; 🇧🇷 Londrina, PR, Brazil

Hospital São José; 🇧🇷 Criciuma, SC, Brazil

Hospital Nereu Ramos; 🇧🇷 Florianópolis, Sc, Brazil

Centro Hospitalar Unimed; 🇧🇷 Joinville, SC, Brazil

Hospital do Coracao; 🇧🇷 São Paulo, Brazil

BP-A Beneficiência Portuguesa de São Paulo; 🇧🇷 São Paulo, Brazil