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

Primary Purpose

Community-acquired Pneumonia, Acute Respiratory Distress Syndrome

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Positive end-expiratory pressure titration with driving pressure control
ARDSNet ventilatory strategy
Sponsored by
Hospital do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring mechanical ventilation, positive end-expiratory pressure, community-acquired pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina
  • Hospital São José
  • Hospital Nereu Ramos
  • Centro Hospitalar Unimed
  • Hospital do Coracao
  • BP-A Beneficiência Portuguesa de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ARDSNet strategy

STAMINA strategy

Arm 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.

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.

Outcomes

Primary Outcome Measures

Mechanical ventilation free days
Number of days patient remains independent of mechanical ventilation

Secondary Outcome Measures

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

Full Information

First Posted
July 15, 2021
Last Updated
August 24, 2023
Sponsor
Hospital do Coracao
Collaborators
Brazilian Research In Intensive Care Network
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1. Study Identification

Unique Protocol Identification Number
NCT04972318
Brief Title
Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia
Acronym
STAMINA
Official Title
Randomized Controlled Trial Comparing Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia: STAMINA
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 4, 2021 (Actual)
Primary Completion Date
November 9, 2023 (Anticipated)
Study Completion Date
January 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao
Collaborators
Brazilian Research In Intensive Care Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia, Acute Respiratory Distress Syndrome
Keywords
mechanical ventilation, positive end-expiratory pressure, community-acquired pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARDSNet strategy
Arm Type
Active Comparator
Arm 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.
Arm Title
STAMINA strategy
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Positive end-expiratory pressure titration with driving pressure control
Other Intervention Name(s)
STAMINA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ARDSNet ventilatory strategy
Intervention Description
Positive end-expiratory pressure will be set according to fixed inspired oxygen fraction values.
Primary Outcome Measure Information:
Title
Mechanical ventilation free days
Description
Number of days patient remains independent of mechanical ventilation
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Hospital Mortality
Description
Whether the patient perished or not during hospitalization
Time Frame
90 days
Title
Intensive Care Unit Mortality
Description
Whether the patient perished or not during intensive care unit stay, truncated at 28 days
Time Frame
90 days
Title
Need for rescue therapies for refractory hypoxemia
Description
Need for extracorporeal membrane oxygenation, alveolar recruitment maneuver, or inhaled nitroux oxide, truncated at 28 days
Time Frame
28 days
Title
Occurrence of barotrauma
Description
Occurrence of either subcutaneous emphysema, pneumothorax or pneumatocele, truncated at 28 days
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Oxygenation parameters (oxygenation index and fraction of arterial pressure of oxygen over inspired oxygen fraction)
Description
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.
Time Frame
3 days
Title
Driving Pressure during mechanical ventilation
Description
Driving pressured, measured once daily and defined by airway plateau pressure minus positive end-expiratory pressure
Time Frame
3 days
Title
Intensive Care Unit Free Days
Description
Number of days the patient spend alive and out of the intensive care unit
Time Frame
28 days
Title
Ventilatory Rate
Description
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
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Israel S Maia, MSc
Organizational Affiliation
HCor Research Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bruno Tomazini, MD
Organizational Affiliation
HCor Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina
City
Londrina
State/Province
PR
Country
Brazil
Facility Name
Hospital São José
City
Criciuma
State/Province
SC
Country
Brazil
Facility Name
Hospital Nereu Ramos
City
Florianópolis
State/Province
Sc
Country
Brazil
Facility Name
Centro Hospitalar Unimed
City
Joinville
State/Province
SC
Country
Brazil
Facility Name
Hospital do Coracao
City
São Paulo
ZIP/Postal Code
05435000
Country
Brazil
Facility Name
BP-A Beneficiência Portuguesa de São Paulo
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share 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.

Learn more about this trial

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

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