You searched for:"Carlos Roberto Ribeiro Carvalho"
We found (3) results for your search.-
Original Articles
Statistical analysis plan for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). A randomized controlled trial
Rev Bras Ter Intensiva. 2017;29(2):142-153
Abstract
Original ArticlesStatistical analysis plan for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). A randomized controlled trial
Rev Bras Ter Intensiva. 2017;29(2):142-153
DOI 10.5935/0103-507X.20170024
Views0See moreABSTRACT
Background:
The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy).
Objective:
To describe the data management process and statistical analysis plan.
Methods:
The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes.
Conclusion:
According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results.
Trial registration:
ClinicalTrials.gov number, NCT01374022.
Views0
Abstract
Original ArticlesStatistical analysis plan for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). A randomized controlled trial
Rev Bras Ter Intensiva. 2017;29(2):142-153
DOI 10.5935/0103-507X.20170024
Views0See moreABSTRACT
Background:
The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy).
Objective:
To describe the data management process and statistical analysis plan.
Methods:
The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes.
Conclusion:
According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results.
Trial registration:
ClinicalTrials.gov number, NCT01374022.
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Original Article
The economic effect of extracorporeal membrane oxygenation to support adults with severe respiratory failure in Brazil: a hypothetical analysis
Rev Bras Ter Intensiva. 2014;26(3):253-262
Abstract
Original ArticleThe economic effect of extracorporeal membrane oxygenation to support adults with severe respiratory failure in Brazil: a hypothetical analysis
Rev Bras Ter Intensiva. 2014;26(3):253-262
DOI 10.5935/0103-507X.20140036
Views0Objective:
To analyze the cost-utility of using extracorporeal oxygenation for patients with severe acute respiratory distress syndrome in Brazil.
Methods:
A decision tree was constructed using databases from previously published studies. Costs were taken from the average price paid by the Brazilian Unified Health System (Sistema Único de Saúde; SUS) over three months in 2011. Using the data of 10,000,000 simulated patients with predetermined outcomes and costs, an analysis was performed of the ratio between cost increase and years of life gained, adjusted for quality (cost-utility), with survival rates of 40 and 60% for patients using extracorporeal membrane oxygenation.
Results:
The decision tree resulted in 16 outcomes with different life support techniques. With survival rates of 40 and 60%, respectively, the increased costs were R$=-301.00/-14.00, with a cost of R$=-30,913.00/-1,752.00 paid per six-month quality-adjusted life-year gained and R$=-2,386.00/-90.00 per quality-adjusted life-year gained until the end of life, when all patients with severe ARDS were analyzed. Analyzing only patients with severe hypoxemia (i.e., a ratio of partial oxygen pressure in the blood to the fraction of inspired oxygen <100mmHg), the increased cost was R$=-5,714.00/272.00, with a cost per six-month quality-adjusted life-year gained of R$=-9,521.00/293.00 and a cost of R$=-280.00/7.00 per quality-adjusted life-year gained.
Conclusion:
The cost-utility ratio associated with the use of extracorporeal membrane oxygenation in Brazil is potentially acceptable according to this hypothetical study.
Keywords:Costs and cost analysisExtracorporeal membrane oxygenation/economyIntensive care unitsRespiration, artificialRespiratory insufficiencySee moreViews0Abstract
Original ArticleThe economic effect of extracorporeal membrane oxygenation to support adults with severe respiratory failure in Brazil: a hypothetical analysis
Rev Bras Ter Intensiva. 2014;26(3):253-262
DOI 10.5935/0103-507X.20140036
Views0Objective:
To analyze the cost-utility of using extracorporeal oxygenation for patients with severe acute respiratory distress syndrome in Brazil.
Methods:
A decision tree was constructed using databases from previously published studies. Costs were taken from the average price paid by the Brazilian Unified Health System (Sistema Único de Saúde; SUS) over three months in 2011. Using the data of 10,000,000 simulated patients with predetermined outcomes and costs, an analysis was performed of the ratio between cost increase and years of life gained, adjusted for quality (cost-utility), with survival rates of 40 and 60% for patients using extracorporeal membrane oxygenation.
Results:
The decision tree resulted in 16 outcomes with different life support techniques. With survival rates of 40 and 60%, respectively, the increased costs were R$=-301.00/-14.00, with a cost of R$=-30,913.00/-1,752.00 paid per six-month quality-adjusted life-year gained and R$=-2,386.00/-90.00 per quality-adjusted life-year gained until the end of life, when all patients with severe ARDS were analyzed. Analyzing only patients with severe hypoxemia (i.e., a ratio of partial oxygen pressure in the blood to the fraction of inspired oxygen <100mmHg), the increased cost was R$=-5,714.00/272.00, with a cost per six-month quality-adjusted life-year gained of R$=-9,521.00/293.00 and a cost of R$=-280.00/7.00 per quality-adjusted life-year gained.
Conclusion:
The cost-utility ratio associated with the use of extracorporeal membrane oxygenation in Brazil is potentially acceptable according to this hypothetical study.
Keywords:Costs and cost analysisExtracorporeal membrane oxygenation/economyIntensive care unitsRespiration, artificialRespiratory insufficiencySee more
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Relatos de Caso
Aspirative pneumonia associated to swallowing dysfunction: case report
Rev Bras Ter Intensiva. 2007;19(1):118-122
Abstract
Relatos de CasoAspirative pneumonia associated to swallowing dysfunction: case report
Rev Bras Ter Intensiva. 2007;19(1):118-122
DOI 10.1590/S0103-507X2007000100016
Views0See moreBACKGROUND AND OBJECTIVES: Critically ill patients represent a population with multiple risk factors for aspiration. Features such as decreased level of consciousness, mechanical ventilation, and comorbities as stroke, correlate with this increased threat in intensive care unit (ICU) patients. Recognition of deglutition dysfunction may identify patients at high risk of aspiration, and thereby help to avoid pulmonary complications such as recurrent pneumonia. The goal of our report is show a severe case of recurrent aspirative pneumonia after acute stroke and intubation, alerting to appropriate diagnosis and treatment of this condition. CASE REPORT: A male patient, 57 year old, was admitted to the hospital because of acute stroke. Ten days later, the patient began to have fever and severe shortness of breath. He was admitted to the ICU necessitating of intratracheal intubation. Four days after intubation he was extubated, however, he had a new aspirative pneumonia in ICU, newly treated. An evaluation of swallowing demonstrated a severe deglutition dysfunction with a high risk of aspiration. The patient was transferred, but aspirative pneumonia was diagnosed eight days after his ICU discharge and he was readmitted, stayed for a long time in ICU and presenting severe morbidity. CONCLUSIONS: ICU patients who are at risk for swallowing dysfunction and aspiration should be identified to prevent their associated morbidity and mortality.
Views0Abstract
Relatos de CasoAspirative pneumonia associated to swallowing dysfunction: case report
Rev Bras Ter Intensiva. 2007;19(1):118-122
DOI 10.1590/S0103-507X2007000100016
Views0See moreBACKGROUND AND OBJECTIVES: Critically ill patients represent a population with multiple risk factors for aspiration. Features such as decreased level of consciousness, mechanical ventilation, and comorbities as stroke, correlate with this increased threat in intensive care unit (ICU) patients. Recognition of deglutition dysfunction may identify patients at high risk of aspiration, and thereby help to avoid pulmonary complications such as recurrent pneumonia. The goal of our report is show a severe case of recurrent aspirative pneumonia after acute stroke and intubation, alerting to appropriate diagnosis and treatment of this condition. CASE REPORT: A male patient, 57 year old, was admitted to the hospital because of acute stroke. Ten days later, the patient began to have fever and severe shortness of breath. He was admitted to the ICU necessitating of intratracheal intubation. Four days after intubation he was extubated, however, he had a new aspirative pneumonia in ICU, newly treated. An evaluation of swallowing demonstrated a severe deglutition dysfunction with a high risk of aspiration. The patient was transferred, but aspirative pneumonia was diagnosed eight days after his ICU discharge and he was readmitted, stayed for a long time in ICU and presenting severe morbidity. CONCLUSIONS: ICU patients who are at risk for swallowing dysfunction and aspiration should be identified to prevent their associated morbidity and mortality.
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Case reports Child Coronavirus infections COVID-19 Critical care Critical illness Extracorporeal membrane oxygenation Infant, newborn Intensive care Intensive care units Intensive care units, pediatric mechanical ventilation Mortality Physical therapy modalities Prognosis Respiration, artificial Respiratory insufficiency risk factors SARS-CoV-2 Sepsis