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

Acute Respiratory Distress Syndrome Clinical Trial

— STAMINA  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04972318
• Other study ID #: stamina_trial
• Status: Terminated
• Phase: N/A
• Start date: September 4, 2021
• Est. completion date: September 21, 2023

Study information

• Verified date: June 2023
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 214
• Est. completion date: September 21, 2023
• Est. primary completion date: September 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Community-acquired Pneumonia
• Pneumonia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital São José	Criciuma	SC
Brazil	Hospital Nereu Ramos	Florianópolis	Sc
Brazil	Centro Hospitalar Unimed	Joinville	SC
Brazil	Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina	Londrina	PR
Brazil	BP-A Beneficiência Portuguesa de São Paulo	São Paulo
Brazil	Hospital do Coracao	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Brazilian Research In Intensive Care Network

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Driving Pressure during mechanical ventilation	Driving pressured, measured once daily and defined by airway plateau pressure minus positive end-expiratory pressure	3 days
Other	Intensive Care Unit Free Days	Number of days the patient spend alive and out of the intensive care unit	28 days
Other	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
Primary	Mechanical ventilation free days	Number of days patient remains independent of mechanical ventilation	28 days
Secondary	Hospital Mortality	Whether the patient perished or not during hospitalization	90 days
Secondary	Intensive Care Unit Mortality	Whether the patient perished or not during intensive care unit stay, truncated at 28 days	90 days
Secondary	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
Secondary	Occurrence of barotrauma	Occurrence of either subcutaneous emphysema, pneumothorax or pneumatocele, truncated at 28 days	28 days