You searched for:"Alexandre Biasi Cavalcanti"
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Clinical Report
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
Crit Care Sci. 2024;36:e20240210en
Abstract
Clinical ReportProspective, 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
Crit Care Sci. 2024;36:e20240210en
DOI 10.62675/2965-2774.20240210-en
Views77ABSTRACT
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.
Keywords:Extracorporeal membrane oxygenationPneumoniaPositive pressure respirationRespiration, artificialRespiratory distress syndromeVentilator-induced lung injurySee more -
Editorial
Challenges and limitations of using ventilator-free days as an outcome in critical care trials
Crit Care Sci. 2024;36:e20240088en
Abstract
EditorialChallenges and limitations of using ventilator-free days as an outcome in critical care trials
Crit Care Sci. 2024;36:e20240088en
DOI 10.62675/2965-2774.20240088-en
Views25The use of ventilator-free days (VFDs) as an outcome measure is increasingly popular in critical care research.(-) This composite outcome simultaneously reflects patient survival and the time not spent on mechanical ventilation (MV) within a specified timeframe, which usually extends from randomization up to Day 28. For patients who do not survive this period, VFDs […]See more -
Special Article
Intensive glucose control in critically ill adults: a protocol for a systematic review and individual patient data meta-analysis
Crit Care Sci. 2023;35(4):345-354
Abstract
Special ArticleIntensive glucose control in critically ill adults: a protocol for a systematic review and individual patient data meta-analysis
Crit Care Sci. 2023;35(4):345-354
DOI 10.5935/2965-2774.20230162-pt
Views19ABSTRACT
Objective:
The optimal target for blood glucose concentration in critically ill patients is unclear. We will perform a systematic review and meta-analysis with aggregated and individual patient data from randomized controlled trials, comparing intensive glucose control with liberal glucose control in critically ill adults.
Data sources:
MEDLINE®, Embase, the Cochrane Central Register of Clinical Trials, and clinical trials registries (World Health Organization, clinical trials.gov). The authors of eligible trials will be invited to provide individual patient data. Published trial-level data from eligible trials that are not at high risk of bias will be included in an aggregated data meta-analysis if individual patient data are not available.
Methods:
Inclusion criteria: randomized controlled trials that recruited adult patients, targeting a blood glucose of ≤ 120mg/dL (≤ 6.6mmol/L) compared to a higher blood glucose concentration target using intravenous insulin in both groups. Excluded studies: those with an upper limit blood glucose target in the intervention group of > 120mg/dL (> 6.6mmol/L), or where intensive glucose control was only performed in the intraoperative period, and those where loss to follow-up exceeded 10% by hospital discharge.
Primary endpoint:
In-hospital mortality during index hospital admission. Secondary endpoints: mortality and survival at other timepoints, duration of invasive mechanical ventilation, vasoactive agents, and renal replacement therapy. A random effect Bayesian meta-analysis and hierarchical Bayesian models for individual patient data will be used.
Discussion:
This systematic review with aggregate and individual patient data will address the clinical question, ‘what is the best blood glucose target for critically ill patients overall?’
Keywords:Blood glucoseCritical illnessGlycemic controlinsulinIntraoperative periodMortalityPatient dischargeRegistriesSee more -
Original Article
Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial
Rev Bras Ter Intensiva. 2022;34(4):410-417
Abstract
Original ArticleEffects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial
Rev Bras Ter Intensiva. 2022;34(4):410-417
DOI 10.5935/0103-507X.20220261-en
Views2ABSTRACT
Objective:
To describe the effects of balanced solution use on the short-term outcomes of patients with traumatic brain injury enrolled in BaSICS trial.
Methods:
Patients were randomized to receive either 0.9% saline or balanced solution during their intensive care unit stay. The primary endpoint was 90-day mortality, and the secondary outcomes were days alive and free of intensive care unit stay at 28 days. The primary endpoint was assessed using Bayesian logistic regression. The secondary endpoint was assessed using a Bayesian zero-inflated beta binomial regression.
Results:
We included 483 patients (236 in the 0.9% saline arm and 247 in the balanced solution arm). A total of 338 patients (70%) with a Glasgow coma scale score ≤ 12 were enrolled. The overall probability that balanced solutions were associated with higher 90-day mortality was 0.98 (OR 1.48; 95%CrI 1.04 – 2.09); this mortality increment was particularly noticeable in patients with a Glasgow coma scale score below 6 at enrollment (probability of harm of 0.99). Balanced solutions were associated with -1.64 days alive and free of intensive care unit at 28 days (95%CrI -3.32 – 0.00) with a probability of harm of 0.97.
Conclusion:
There was a high probability that balanced solutions were associated with high 90-day mortality and fewer days alive and free of intensive care units at 28 days.
Keywords:Balanced solutionsBrain injuriesCritical careHospital mortalityMortalitySaline solutiontraumaticSee more -
Original Article
IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units
Rev Bras Ter Intensiva. 2022;34(4):418-425
Abstract
Original ArticleIMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units
Rev Bras Ter Intensiva. 2022;34(4):418-425
DOI 10.5935/0103-507X.20220209-en
Views2ABSTRACT
Objective:
To describe the IMPACTO-MR, a Brazilian nationwide intensive care unit platform study focused on the impact of health care-associated infections due to multidrug-resistant bacteria.
Methods:
We described the IMPACTO-MR platform, its development, criteria for intensive care unit selection, characterization of core data collection, objectives, and future research projects to be held within the platform.
Results:
The core data were collected using the Epimed Monitor System® and consisted of demographic data, comorbidity data, functional status, clinical scores, admission diagnosis and secondary diagnoses, laboratory, clinical, and microbiological data, and organ support during intensive care unit stay, among others. From October 2019 to December 2020, 33,983 patients from 51 intensive care units were included in the core database.
Conclusion:
The IMPACTO-MR platform is a nationwide Brazilian intensive care unit clinical database focused on researching the impact of health care-associated infections due to multidrug-resistant bacteria. This platform provides data for individual intensive care unit development and research and multicenter observational and prospective trials.
Keywords:bacterialBacterial infectionsDatabaseDatabase management systemsDrug-resistanceIMPACTO-MRIntensive care unitsSoftwareSee more -
Special Article
Automated documentation of vital parameters in wards using portable stations – Effect on proper triggering of the rapid response team: a study protocol of a cluster randomized clinical trial
Rev Bras Ter Intensiva. 2022;34(3):319-326
Abstract
Special ArticleAutomated documentation of vital parameters in wards using portable stations – Effect on proper triggering of the rapid response team: a study protocol of a cluster randomized clinical trial
Rev Bras Ter Intensiva. 2022;34(3):319-326
DOI 10.5935/0103-507X.20220101-en
Views2ABSTRACT
Objective:
To evaluate the effectiveness of the Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ solution in activating the rapid response team in a timely manner compared to manual activation.
Methods:
The Hillrom study is a single-center, open-label, superiority, cluster-randomized, parallel-group (1:1 allocation ratio) clinical trial that will be conducted in a tertiary hospital. Two sets of three wards with 28 beds will be included (one as the intervention cluster and the other as the control). The wards will be randomly assigned to use the Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ automated solution (intervention cluster) or to maintain the usual routine (control cluster) regarding rapid response team activation. The primary outcome will be the absolute number of episodes of rapid response team triggering in an appropriate time; as secondary outcomes, clinical features (mortality, cardiac arrest, need for intensive care unit admission and duration of hospitalization) will be assessed according to clusters in an exploratory way. A sample size of 216 rapid response team activations was estimated to identify a possible difference between the groups. The protocol has been approved by the institutional Research Ethics Committee.
Expected results:
The Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ automated solution is expected to be more effective in triggering the nurse call system to activate the rapid response team in a timely and adequate manner compared to manual triggering (usual practice).
ClinicalTrials.gov:
NCT04648579
Keywords:computerizedHealth information interoperabilityHospital rapid response teamMedical records systemsNursing stationsVital signsSee more -
Original Article
Clinical outcomes and lung mechanics characteristics between COVID-19 and non-COVID-19-associated acute respiratory distress syndrome: a propensity score analysis of two major randomized trials
Rev Bras Ter Intensiva. 2022;34(3):335-341
Abstract
Original ArticleClinical outcomes and lung mechanics characteristics between COVID-19 and non-COVID-19-associated acute respiratory distress syndrome: a propensity score analysis of two major randomized trials
Rev Bras Ter Intensiva. 2022;34(3):335-341
DOI 10.5935/0103-507X.20220040-en
Views3ABSTRACT
Objective:
To compare the lung mechanics and outcomes between COVID-19-associated acute respiratory distress syndrome and non-COVID-19-associated acute respiratory distress syndrome.
Methods:
We combined data from two randomized trials in acute respiratory distress syndrome, one including only COVID-19 patients and the other including only patients without COVID-19, to determine whether COVID-19-associated acute respiratory distress syndrome is associated with higher 28-day mortality than non-COVID-19 acute respiratory distress syndrome and to examine the differences in lung mechanics between these two types of acute respiratory distress syndrome.
Results:
A total of 299 patients with COVID-19-associated acute respiratory distress syndrome and 1,010 patients with non-COVID-19-associated acute respiratory distress syndrome were included in the main analysis. The results showed that non-COVID-19 patients used higher positive end-expiratory pressure (12.5cmH2O; SD 3.2 versus 11.7cmH2O SD 2.8; p < 0.001), were ventilated with lower tidal volumes (5.8mL/kg; SD 1.0 versus 6.5mL/kg; SD 1.2; p < 0.001) and had lower static respiratory compliance adjusted for ideal body weight (0.5mL/cmH2O/kg; SD 0.3 versus 0.6mL/cmH2O/kg; SD 0.3; p = 0.01). There was no difference between groups in 28-day mortality (52.3% versus 58.9%; p = 0.52) or mechanical ventilation duration in the first 28 days among survivors (13 [IQR 5 – 22] versus 12 [IQR 6 – 26], p = 0.46).
Conclusion:
This analysis showed that patients with non-COVID-19-associated acute respiratory distress syndrome have different lung mechanics but similar outcomes to COVID-19-associated acute respiratory distress syndrome patients. After propensity score matching, there was no difference in lung mechanics or outcomes between groups.
Keywords:Coronavirus infectionsCOVID-19Critical careCritical care outcomesRespiratory distress syndromeRespiratory mechanicsSee more
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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