Clinical trial NCT04972318: Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Community-acquired Pneumonia
Acute Respiratory Distress Syndrome
Keywords: mechanical ventilation
positive end-expiratory pressure
community-acquired pneumonia
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Brazilian Research In Intensive Care Network
First posted: 2021-07-22
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mechanical ventilation free days
timeFrame: 28 days
Secondary outcomes:
measure: Hospital Mortality
timeFrame: 90 days
measure: Intensive Care Unit Mortality
timeFrame: 90 days
measure: Need for rescue therapies for refractory hypoxemia
timeFrame: 28 days
measure: Occurrence of barotrauma
timeFrame: 28 days
Other outcomes:
measure: Oxygenation parameters (oxygenation index and fraction of arterial pressure of oxygen over inspired oxygen fraction)
timeFrame: 3 days
measure: Driving Pressure during mechanical ventilation
timeFrame: 3 days
measure: Intensive Care Unit Free Days
timeFrame: 28 days
measure: Ventilatory Rate
timeFrame: 3 days
Locations:
city: Londrina
country: Brazil
facility: Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina
state: PR
city: Criciuma
country: Brazil
facility: Hospital São José
state: SC
city: Florianópolis
country: Brazil
facility: Hospital Nereu Ramos
state: Sc
city: Joinville
country: Brazil
facility: Centro Hospitalar Unimed
state: SC
city: São Paulo
country: Brazil
facility: Hospital do Coracao
city: São Paulo
country: Brazil
facility: BP-A Beneficiência Portuguesa de São Paulo
Study officials:
affiliation: HCor Research Institute
name: Israel S Maia, MSc
role: STUDY_CHAIR
affiliation: HCor Research Institute
name: Bruno Tomazini, MD
role: PRINCIPAL_INVESTIGATOR
References: