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

Sponsor

Hospital do Coracao (Other)

Overall Status

Recruiting

CT.gov ID

NCT04972318

Collaborator

Brazilian Research in Intensive Care Network (BRICNet) (Other)

500

Enrollment

Locations

Arms

26.9

Anticipated Duration (Months)

83.3

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia Acute Respiratory Distress Syndrome	Procedure: Positive end-expiratory pressure titration with driving pressure control Procedure: ARDSNet ventilatory strategy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Trial Comparing Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia: STAMINA

Actual Study Start Date :

Sep 4, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mechanical ventilation free days [28 days]
Number of days patient remains independent of mechanical ventilation

Secondary Outcome Measures

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

Other Outcome Measures

Oxygenation parameters (oxygenation index and fraction of arterial pressure of oxygen over inspired oxygen fraction) [3 days]
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.
Driving Pressure during mechanical ventilation [3 days]
Driving pressured, measured once daily and defined by airway plateau pressure minus positive end-expiratory pressure
Intensive Care Unit Free Days [28 days]
Number of days the patient spend alive and out of the intensive care unit
Ventilatory Rate [3 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina	Londrina	PR	Brazil
2	Hospital São José	Criciuma	SC	Brazil
3	Hospital Nereu Ramos	Florianópolis	Sc	Brazil
4	Centro Hospitalar Unimed	Joinville	SC	Brazil
5	Hospital do Coracao	São Paulo		Brazil	05435000
6	BP-A Beneficiência Portuguesa de São Paulo	São Paulo		Brazil