Community-acquired PneumoniaSTAMINANCT04972318
Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia
A study testing ARDSNet ventilatory strategy in people with Community-acquired Pneumonia and Acute Respiratory Distress Syndrome, run by Hospital do Coracao at 6 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Acute Respiratory Distress Syndrome
- What is being tested?
- ARDSNet ventilatory strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 6 sitesBrazil
- Study dates
- 4 Sep 2021to 21 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Hospital São José
Criciúma, Santa Catarina
Hospital Nereu Ramos
Florianópolis, Santa Catarina
Centro Hospitalar Unimed
Joinville, Santa Catarina
Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina
Londrina, Paraná
Hospital do Coracao
São Paulo, 05435000
BP-A Beneficiência Portuguesa de São Paulo
São Paulo
About this study
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)
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.
Read the 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.
- Being tested
- Positive end-expiratory pressure titration with driving pressure control, ARDSNet ventilatory strategy
- Keywords
- mechanical ventilation, positive end-expiratory pressure, community-acquired pneumonia
- Medical subject headings
- Community-Acquired Pneumonia, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive end-expiratory pressure titration with driving pressure controlProcedure or surgery
Also called STAMINA
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 strategyProcedure or surgery
Positive end-expiratory pressure will be set according to fixed inspired oxygen fraction values.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Positive end-expiratory pressure titration with driving pressure control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation free days
Number of days patient remains independent of mechanical ventilation
Measured: 28 days
Secondary outcomes (4)
Hospital Mortality
Whether the patient perished or not during hospitalization
Measured: 90 days
Intensive Care Unit Mortality
Whether the patient perished or not during intensive care unit stay, truncated at 28 days
Measured: 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
Measured: 28 days
Occurrence of barotrauma
Occurrence of either subcutaneous emphysema, pneumothorax or pneumatocele, truncated at 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start4 Sep 2021
- Primary completion9 Sep 2023
- Study completion21 Sep 2023
Why it stopped: Low recruitment rate with no possibility to achieve pre specified sample size before funding ends.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Brazilian Research In Intensive Care Network
- Responsible party
- Sponsor
- Investigators
- Israel S Maia, MSc, Study chair, HCor Research InstituteBruno Tomazini, MD, Principal investigator, HCor Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972318
- Sponsor's protocol ID
- stamina_trial
- Acronym
- STAMINA
- Status last verified
- Jun 2023
- First submitted
- 15 Jul 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39592365
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04972318
- Acronym / sponsor ID
- STAMINA / stamina_trial
- Keywords
- mechanical ventilation, positive end-expiratory pressure, community-acquired pneumonia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate with no possibility to achieve pre specified sample size before funding ends.
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Brazilian Research In Intensive Care Network
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 9 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDSNet strategy | Active comparator | Procedure: ARDSNet ventilatory strategyPatients 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. |
| STAMINA strategy | Experimental | Procedure: Positive end-expiratory pressure titration with driving pressure controlPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive end-expiratory pressure titration with driving pressure controlAlso: STAMINAPositive 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. | Procedure or surgery | STAMINA strategy |
| ARDSNet ventilatory strategyPositive end-expiratory pressure will be set according to fixed inspired oxygen fraction values. | Procedure or surgery | ARDSNet strategy |
Primary outcome
Mechanical ventilation free days
Time frame: 28 days
Number of days patient remains independent of mechanical ventilation
4 secondary outcomes
Hospital Mortality
Time frame: 90 days
Intensive Care Unit Mortality
Time frame: 90 days
Need for rescue therapies for refractory hypoxemia
Time frame: 28 days
Occurrence of barotrauma
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Low recruitment rate with no possibility to achieve pre specified sample size before funding ends.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 39592365Maia 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Israel S Maia, MSc study chair
HCor Research Institute
Bruno Tomazini, MD principal investigator
HCor Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARDSNet ventilatory strategy in people with Community-acquired Pneumonia and Acute Respiratory Distress Syndrome, run by Hospital do Coracao at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment rate with no possibility to achieve pre specified sample size before funding ends.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical ventilation free days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04972318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.