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): protocol and statistical analysis plan.

BACKGROUND: Driving pressure has been suggested to be the main driver of ventilator-induced lung injury and mortality in observational studies of acute respiratory distress syndrome. Whether a driving pressure-limiting strategy can improve clinical outcomes is unclear. OBJECTIVE: To describe the protocol and statistical analysis plan that will be used to test whether a driving pressure-limiting strategy including positive end-expiratory pressure titration according to the best respiratory compliance and reduction in tidal volume is superior to a standard strategy involving the use of the ARDSNet low-positive end-expiratory pressure table in terms of increasing the number of ventilator-free days in patients with acute respiratory distress syndrome due to community-acquired pneumonia. METHODS: The ventilator STrAtegy for coMmunIty acquired pNeumoniA (STAMINA) study is a randomized, multicenter, open-label trial that compares a driving pressure-limiting strategy to the ARDSnet low-positive end-expiratory pressure table in patients with moderate-to-severe acute respiratory distress syndrome due to community-acquired pneumonia admitted to intensive care units. We expect to recruit 500 patients from 20 Brazilian and 2 Colombian intensive care units. They will be randomized to a driving pressure-limiting strategy group or to a standard strategy using the ARDSNet low-positive end-expiratory pressure table. In the driving pressure-limiting strategy group, positive end-expiratory pressure will be titrated according to the best respiratory system compliance. OUTCOMES: The primary outcome is the number of ventilator-free days within 28 days. The secondary outcomes are in-hospital and intensive care unit mortality and the need for rescue therapies such as extracorporeal life support, recruitment maneuvers and inhaled nitric oxide. CONCLUSION: STAMINA is designed to provide evidence on whether a driving pressure-limiting strategy is superior to the ARDSNet low-positive end-expiratory pressure table strategy for increasing the number of ventilator-free days within 28 days in patients with moderate-to-severe acute respiratory distress syndrome. Here, we describe the rationale, design and status of the trial.

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): protocol and statistical analysis plan / Estudo randomizado prospectivo e controlado de avaliação dos efeitos de uma estratégia de limitação da driving pressure em pacientes com síndrome do desconforto respiratório agudo devido à pneumonia adquirida na comunidade (estudo STAMINA): protocolo e plano de análise estatística

ABSTRACT Background: Driving pressure has been suggested to be the main driver of ventilator-induced lung injury and mortality in observational studies of acute respiratory distress syndrome. Whether a driving pressure-limiting strategy can improve clinical outcomes is unclear. Objective: To describe the protocol and statistical analysis plan that will be used to test whether a driving pressure-limiting strategy including positive end-expiratory pressure titration according to the best respiratory compliance and reduction in tidal volume is superior to a standard strategy involving the use of the ARDSNet low-positive end-expiratory pressure table in terms of increasing the number of ventilator-free days in patients with acute respiratory distress syndrome due to community-acquired pneumonia. Methods: The ventilator STrAtegy for coMmunIty acquired pNeumoniA (STAMINA) study is a randomized, multicenter, open-label trial that compares a driving pressure-limiting strategy to the ARDSnet low-positive end-expiratory pressure table in patients with moderate-to-severe acute respiratory distress syndrome due to community-acquired pneumonia admitted to intensive care units. We expect to recruit 500 patients from 20 Brazilian and 2 Colombian intensive care units. They will be randomized to a driving pressure-limiting strategy group or to a standard strategy using the ARDSNet low-positive end-expiratory pressure table. In the driving pressure-limiting strategy group, positive end-expiratory pressure will be titrated according to the best respiratory system compliance. Outcomes: The primary outcome is the number of ventilator-free days within 28 days. The secondary outcomes are in-hospital and intensive care unit mortality and the need for rescue therapies such as extracorporeal life support, recruitment maneuvers and inhaled nitric oxide. Conclusion: STAMINA is designed to provide evidence on whether a driving pressure-limiting strategy is superior to the ARDSNet low-positive end-expiratory pressure table strategy for increasing the number of ventilator-free days within 28 days in patients with moderate-to-severe acute respiratory distress syndrome. Here, we describe the rationale, design and status of the trial.

RESUMO Contexto: Em estudos observacionais sobre a síndrome do desconforto respiratório agudo, sugeriu-se que a driving pressure é o principal fator de lesão pulmonar induzida por ventilador e de mortalidade. Não está claro se uma estratégia de limitação da driving pressure pode melhorar os desfechos clínicos. Objetivo: Descrever o protocolo e o plano de análise estatística que serão usados para testar se uma estratégia de limitação da driving pressure envolvendo a titulação da pressão positiva expiratória final de acordo com a melhor complacência respiratória e a redução do volume corrente é superior a uma estratégia padrão envolvendo o uso da tabela de pressão positiva expiratória final baixa do protocolo ARDSNet, em termos de aumento do número de dias sem ventilador em pacientes com síndrome do desconforto respiratório agudo devido à pneumonia adquirida na comunidade. Métodos: O estudo STAMINA (ventilator STrAtegy for coMmunIty acquired pNeumoniA) é randomizado, multicêntrico e aberto e compara uma estratégia de limitação da driving pressure com a tabela de pressão positiva expiratória final baixa do protocolo ARDSnet em pacientes com síndrome do desconforto respiratório agudo moderada a grave devido à pneumonia adquirida na comunidade internados em unidades de terapia intensiva. Esperamos recrutar 500 pacientes de 20 unidades de terapia intensiva brasileiras e duas colombianas. Eles serão randomizados para um grupo da estratégia de limitação da driving pressure ou para um grupo de estratégia padrão usando a tabela de pressão positiva expiratória final baixa do protocolo ARDSnet. No grupo da estratégia de limitação da driving pressure, a pressão positiva expiratória final será titulada de acordo com a melhor complacência do sistema respiratório. Desfechos: O desfecho primário é o número de dias sem ventilador em 28 dias. Os desfechos secundários são a mortalidade hospitalar e na unidade de terapia intensiva e a necessidade de terapias de resgate, como suporte de vida extracorpóreo, manobras de recrutamento e óxido nítrico inalado. Conclusão: O STAMINA foi projetado para fornecer evidências sobre se uma estratégia de limitação da driving pressure é superior à estratégia da tabela de pressão positiva expiratória final baixa do protocolo ARDSnet para aumentar o número de dias sem ventilador em 28 dias em pacientes com síndrome do desconforto respiratório agudo moderada a grave. Aqui, descrevemos a justificativa, o desenho e o status do estudo.

Functional Recovery Groups in Critically Ill COVID-19 Patients and Their Associated Factors: From ICU to Hospital Discharge.

OBJECTIVES: To analyze functional recovery groups of critically ill COVID-19 survivors during their hospital stay and to identify the associated factors. DESIGN: Prospective observational multicenter study. SETTING: Demographic, clinical, and therapeutic variables were collected, and physical and functional status were evaluated. The Barthel index was evaluated at three time points: 15 days before hospitalization, at ICU discharge, and at hospital discharge from the ward. PATIENTS: Patients with functional independence before COVID-19 diagnosis were recruited from four hospitals and followed up until hospital discharge. MEASUREMENTS AND MAIN RESULTS: Three groups of functional recovery were described for 328 patients: functional independence ( n = 144; 44%), which included patients who preserved their functional status during hospitalization; recovered functionality ( n = 109; 33.2%), which included patients who showed dependence at ICU discharge but recovered their independence by hospital discharge; and functional dependency ( n = 75; 22.8%), which included patients who were dependent at ICU discharge and had not recovered their functional status at hospital discharge. The factors associated with becoming functionally dependent at ICU discharge were time to out-of-bed patient mobilization (odds ratio [OR], 1.20; 95% CI, 1.11-1.29), age (OR, 1.02; 95% CI, 1.01-1.04), hyperglycemia (OR, 2.52; 95% CI, 1.56-4.07), and Simplified Acute Physiology Score (OR, 1.022; 95% CI, 1.01-1.04). Recovery to baseline independence during ward stays was associated with ICU length of stay (OR, 0.97; 95% CI, 0.94-0.99) and muscle strength (Medical Research Council test) at ICU discharge (OR, 1.13; 95% CI, 1.08-1.18). CONCLUSIONS: Age, hyperglycemia, and time for patient mobilization out of bed were independent factors associated with becoming physically dependent after their ICU stay. Recovery of physical function at hospital discharge was associated with muscle strength at ICU discharge and length of ICU stay.

The effects of recruitment maneuver during noninvasive ventilation after coronary bypass grafting: A randomized trial.

OBJECTIVE: Pulmonary impairment is a common complication after coronary artery bypass graft procedure and may be prevented or treated by noninvasive ventilation. Recruitment maneuvers include sustained airway pressure with high levels of positive end-expiratory pressure in patients with hypoxemia, favoring homogeneous pulmonary ventilation and oxygenation. This study aimed to evaluate whether noninvasive ventilation with recruitment maneuver could safely improve oxygenation in patients with atelectasis and hypoxemia who underwent a coronary artery bypass grafting procedure. METHODS: Thirty-four patients admitted to our intensive care unit undergoing mechanical ventilation after surgery, with ratio of arterial oxygen partial pressure to fraction of inspired oxygen < 300 and radiologic atelectasis score ≥2, were included. The control group consisted of 16 randomized patients and the recruitment group consisted of 18 patients. After extubation, noninvasive ventilation was applied for 30 minutes 3 times a day with positive end-expiratory pressure of 8 cm H2O. The recruitment group received recruitment maneuver with positive end-expiratory pressure of 15 cm H2O and 20 cm H2O for 2 minutes each during noninvasive ventilation. We analyzed the arterial oxygen partial pressure in room air, radiologic atelectasis score, hemodynamic stability, and adverse events from extubation until discharge. RESULTS: Arterial oxygen partial pressure increased 12.6% ± 6.8% in the control group and 23.3% ± 8.5% in the recruitment group (P < .001). The radiologic atelectasis score was completely improved for 94.4% of the recruitment group with no adverse events, whereas 87.5% of the control group presented some atelectasis (P < .001). CONCLUSIONS: Noninvasive ventilation with recruitment maneuvers is safe, improves oxygenation, and reduces atelectasis in patients undergoing coronary artery bypass.