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

NCT04972318 | Terminated DMC

• 1 other identifier: stamina_trial
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 6

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.

Conditions

Community-acquired Pneumonia; Acute Respiratory Distress Syndrome

Keywords

mechanical ventilation; positive end-expiratory pressure; community-acquired pneumonia

Outcome Measures

Primary Outcomes (1)

• Mechanical ventilation free days

  Number of days patient remains independent of mechanical ventilation

  28 days

Secondary Outcomes (4)

• Hospital Mortality

  90 days

• Intensive Care Unit Mortality

  90 days

• Need for rescue therapies for refractory hypoxemia

  28 days

• Occurrence of barotrauma

  28 days

Other Outcomes (4)

• Oxygenation parameters (oxygenation index and fraction of arterial pressure of oxygen over inspired oxygen fraction)

  3 days

• Driving Pressure during mechanical ventilation

  3 days

• Intensive Care Unit Free Days

  28 days

Study Arms (2)

ARDSNet strategy

ACTIVE COMPARATOR

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.

Procedure: ARDSNet ventilatory strategy

STAMINA strategy

EXPERIMENTAL

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.

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

Interventions

Positive end-expiratory pressure titration with driving pressure control PROCEDURE

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.

Also known as: STAMINA

STAMINA strategy

ARDSNet ventilatory strategy PROCEDURE

Positive end-expiratory pressure will be set according to fixed inspired oxygen fraction values.

ARDSNet strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital do Coracao: lead
• Brazilian Research In Intensive Care Network: collaborator

Study Sites (6)

Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina

Londrina, Paraná, Brazil

Location

Hospital São José

Criciúma, Santa Catarina, Brazil

Location

Hospital Nereu Ramos

Florianópolis, Santa Catarina, Brazil

Location

Centro Hospitalar Unimed

Joinville, Santa Catarina, Brazil

Location

Hospital do Coracao

São Paulo, 05435000, Brazil

Location

BP-A Beneficiência Portuguesa de São Paulo

São Paulo, Brazil

Location

Related Publications (1)

• Maia IS, Cavalcanti AB, Tramujas L, Veiga VC, Oliveira JS, Sady ERR, Barbante LG, Nicola ML, Gurgel RM, Damiani LP, Negrelli KL, Miranda TA, Laranjeira LN, Tomazzini B, Zandonai C, Pincelli MP, Westphal GA, Fernandes RP, Figueiredo R, Sartori Bustamante CL, Norbin LF, Boschi E, Lessa R, Romano MP, Miura MC, Soares de Alencar Filho M, Ces de Souza Dantas V, Barreto PA, Hernandes ME, Grion C, Laranjeira AS, Mezzaroba AL, Bahl M, Starke AC, Biondi R, Dal-Pizzol F, Caser E, Thompson MM, Padial AA, Leite RT, Araujo G, Guimaraes M, Aquino P, Lacerda F, Hoffmann Filho CR, Melro L, Pacheco E, Ospina-Tascon G, Ferreira JC, Calado Freires FJ, Machado FR, Zampieri FG; BRICNet. Effect of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome secondary to community-acquired pneumonia: the STAMINA randomised clinical trial. Br J Anaesth. 2025 Mar;134(3):693-702. doi: 10.1016/j.bja.2024.10.012. Epub 2024 Nov 26.

  PMID: 39592365 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia; Respiratory Distress Syndrome

Interventions

Physical Endurance

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Israel S Maia, MSc

  HCor Research Institute

  STUDY CHAIR

• Bruno Tomazini, MD

  HCor Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 22, 2021
• Study Start: September 4, 2021
• Primary Completion: September 9, 2023
• Study Completion: September 21, 2023
• Last Updated: February 5, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after publication of primary results
• Access Criteria: Submission of a statistical analysis plan for the purposed analyses. Compliance with Brazilian. data privacy law.

Locations

BR (6)