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

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)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • BP-A Beneficiência Portuguesa de São Paulo
  • São Paulo, Brazil, 05435000
    • Hospital do Coração
  • PR
    • Londrina, PR, Brazil
      • Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina
  • SC
    • Criciuma, SC, Brazil
      • Hospital Sao Jose
    • Joinville, SC, Brazil
      • Centro Hospitalar Unimed
  • Sc
    • Florianópolis, Sc, Brazil
      • Hospital Nereu Ramos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARDSNet 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.	Procedure: ARDSNet ventilatory strategy; Positive end-expiratory pressure will be set according to fixed inspired oxygen fraction values.
Experimental: STAMINA strategy; 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; 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.; Other Names: STAMINA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical ventilation free days	Number of days patient remains independent of mechanical ventilation	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Mortality	Whether the patient perished or not during hospitalization	90 days
Intensive Care Unit Mortality	Whether the patient perished or not during intensive care unit stay, truncated at 28 days	90 days
Need for rescue therapies for refractory hypoxemia	Need for extracorporeal membrane oxygenation, alveolar recruitment maneuver, or inhaled nitroux oxide, truncated at 28 days	28 days
Occurrence of barotrauma	Occurrence of either subcutaneous emphysema, pneumothorax or pneumatocele, truncated at 28 days	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation parameters (oxygenation index and fraction of arterial pressure of oxygen over inspired oxygen fraction)	Measurements of oxygenation in the first 3 days after enrollment (ratio between arterial partial pressure of oxygen over inspired fraction of oxygen, and oxygenation index, defined by mean airway pressure multiplied by fraction of inspired oxygen over arterial partial pressure of oxygen.	3 days
Driving Pressure during mechanical ventilation	Driving pressured, measured once daily and defined by airway plateau pressure minus positive end-expiratory pressure	3 days
Intensive Care Unit Free Days	Number of days the patient spend alive and out of the intensive care unit	28 days
Ventilatory Rate	Ventilatory Rate, measured daily, defined as minute ventilation (in liters) multiplied by arterial partial pressure of oxygen, divided by 37.5 multiplied by patient weight (in kilograms) multiplied by 100	3 days

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Collaborators: Brazilian Research In Intensive Care Network
• Investigators: Principal Investigator: Bruno Tomazini, MD, HCor Research Institute; Study Chair: Israel S Maia, MSc, HCor Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2021
• Primary Completion (Actual): September 9, 2023
• Study Completion (Actual): September 21, 2023

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: mechanical ventilation; positive end-expiratory pressure; community-acquired pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Pneumonia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: stamina_trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 1 year after publication of primary results
• IPD Sharing Access Criteria: Submission of a statistical analysis plan for the purposed analyses. Compliance with Brazilian. data privacy law.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No