Clinical Research Directory

A New Tool for Extubation Readiness in Mechanically Ventilated Patients: Readiness for EXtubation Score

Liberation from mechanical ventilation involves three steps: weaning, readiness assessment, and extubation. Readiness is determined using clinical criteria such as improvement of the underlying condition, hemodynamic stability, and adequate respiratory effort. Successful extubation is defined as not requiring invasive support within 48 hours. Due to the complexity of ICU patients, various clinical parameters and multi-component scores have been developed to predict extubation success. This study aims to develop and evaluate a multi-component score, the Readiness for EXtubation score (REXs), to predict extubation readiness in ICU patients under invasive mechanical ventilation.

Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning From Mechanical Ventilation

The objective of this study is to evaluate the efficacy of the VentFree Respiratory Muscle Stimulator (VentFree) in critically ill adult patients who require invasive mechanical ventilation, when compared to sham.

Optimal Timing for Spontaneous Breathing Trials

This study aims to explore how the timing of Spontaneous Breathing Trials (SBTs) affects recovery in adult patients who are on mechanical ventilation in the ICU. SBTs are tests used to determine if a patient is ready to breathe on their own without the help of a ventilator. The study will compare two different timing strategies for these trials: one group of patients will have the test early in the morning, while the other group will have it later in the morning. By observing the outcomes, such as how long patients need to stay on the ventilator, the study hopes to find the best time to perform these trials to help patients recover more quickly and safely.

High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery

High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery

Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation

Effective respiratory ventilation is achieved by moving the right amount of air in and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this non-inferiority study, we will perform a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.

Epidemiology of Non- Invasive Mechanical Ventilation in Argentina: a Multicenter Observational Study

Introduction Non-invasive mechanical ventilation (NIMV) is a fundamental strategy in the management of acute respiratory failure, preventing intubation and reducing complications. However, the epidemiology of its use in Argentina is not well understood, motivating this study. Justification Unequal access to ICU resources in Argentina affects the quality of care. This study aims to describe the implementation, effectiveness, and outcomes of NIMV across different regions of the country to improve clinical decision-making and healthcare policies. Objectives * Primary: Analyze the survival of ICU patients receiving NIMV. * Secondary: Evaluate success/failure factors, regional disparities in resource availability, the impact of healthcare staff training, comparison between public and private sectors, and establish a national database. Methods Study Design Observational, multicenter, prospective, and analytical study. Both public and private hospitals in Argentina will be included. Data will be collected over seven months, with patient follow-up until discharge or death. Study Population Adult patients (\>18 years) admitted to the ICU requiring NIMV for acute respiratory failure or as part of weaning from invasive mechanical ventilation. Inclusion Criteria * Age \>18 years. * Use of NIMV in the ICU for respiratory failure or during weaning. * Signed informed consent. Exclusion Criteria * Patients using home NIMV without exacerbation. * Patients without acute respiratory impairment. Data Collection and Management * Data will be recorded using an electronic form in RedCap®, with restricted access. * Confidentiality will be ensured through alphanumeric coding. * A monitoring committee will supervise data quality. Statistical Analysis * Continuous variables: Mean and standard deviation or median and interquartile range. * Comparisons: Student's t-test, Mann-Whitney U test, Chi² test, or Fisher's exact test. * Multivariate models: Logistic regression and Kaplan-Meier survival analysis. Bias Control and Data Quality Strategies will be implemented to minimize selection, information, and investigator bias. Data will be periodically reviewed by the monitoring committee. Study Feasibility The study is supported by the British Hospital of Buenos Aires and the Argentine Society of Intensive Care Medicine, ensuring its viability. Ethical Considerations The study will comply with national and international health research regulations, ensuring participant confidentiality. Publication and Funding The study will be funded by the Argentine Society of Intensive Care Medicine, with no external financial support. Authorship in publications will depend on the number of patients included per center. Conclusion This study aims to generate key information on NIMV use in Argentina, optimizing its application and improving ICU care nationwide.

Susceptibility for Entrainment: Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study

Background: Reverse triggering (RT) is a frequent phenomenon observed in sedated patients under a mechanical ventilation mode called assist-control ventilation. RT is when the ventilator would trigger the patient's respiratory effort instead of the correct order of the patient's respiratory effort triggering the ventilator. Reverse triggering can have negative consequences (loss of protective lung ventilation, and causing double breaths - with the ventilator giving two consecutive breaths and not allowing the patient to exhale) but also offer some protective effects (avoid diaphragm disuse atrophy). The balance of its negative vs positive effects depends on its frequency and magnitude of its associated respiratory effort. Respiratory entrainment is the most often referred mechanism involving a change in patient's rate of breathing effort from that of patient's intrinsic rate to the rate of mechanical insufflation. The specific ventilatory settings associated with or responsible for RT remains unknown. Aims: To assess in mechanically ventilated critically ill patients the influence of the set respiratory rate (RR) and tidal volume (Vt) on the presence/development of RT and to describe the pattern of respiratory muscle activity during Reverse Triggering (RT). Methods. 30 adult patients (15 in each group), sedated and under assist-controlled ventilation will be included. Ventilator settings will be modified to modulate the frequency and magnitude of reverse triggering. Initially, with the ventilator on a mode called volume control, which means the ventilator controls the amount of air (tidal volume) and the number of breaths the patients gets every minute (respiratory rate \[RR\]). The tidal volume will be set at the current standard clinical practice setting (6 ml/kg of predicted body weight). The presence of an intrinsic respiratory rate will be assessed with an end-expiratory occlusion maneuver. Next, the number of breaths the ventilator gives per minute (RR) will be changed from 6 breaths less to 6 breaths more, in steps of 2 breaths every minute. The protocol will be repeated again changing the amount of air the patients gets (tidal volume) from 4, 5, 7 and 8 ml/kg. Continuous recordings of airway pressure, flow, esophageal pressure, electrical activity of the diaphragm, main accessory muscles and frontal electroencephalography will be obtained during the protocol and baseline clinical and physiological characteristics and outcomes will be recorded. A validated software will be used to detect RT and measure the intensity and timing of each muscle electrical activity and the magnitude of the inspiratory effort during RT.

Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation

This is a multicentre prospective cohort trial in adult and pediatric ICU patients. The investigators will measure the effect of a patient's inspiratory effort during mechanical ventilation on the lungs and diaphragm. The investigators will daily (for a maximum of 8 days) measure esophageal pressures with a balloon catheter to quantify inspiratory effort and respiratory muscle function, and perform daily ultrasound measurements of the diaphragm and the lungs. The investigators hypothesize that a small inspiratory effort will result in the preservation of diaphragm function and have no adverse effect on lung function.

Analysis of the Evolution of Mortality in an Intensive Care Unit

The intensive care units is of the main components of modern healthcare systems. Formally, its aim is to offer the critically ill health care fit to their needs; ensuring that this health care is appropriate, sustainable, ethical and respectful of their autonomy. Intensive medicine is a cross-sectional specialty that encompasses a broad spectrum of pathologies in their most severe condition, and specifically has as its foundation the practice of comprehensive care of the patient with organ dysfunction and susceptible to recovery. Although critically ill patients are a heterogeneous population, they have in common the need for a high level of care, often requiring the use of high technology, specific procedures for the support of organ dysfunction and the collaboration of other medical and surgical specialties for their management and treatment. Since their origins in the late 1950s, intensive care units have been adapting to the changes arising from the best scientific evidence. In the late 1990s and early 2000s, there were some successful clinical trials published that had tested alternative management strategies in the ICU. Mechanical ventilation is an intervention that defines the critical care specialty. Between 1970 and the 1990s, the management focused on normalizing arterial blood gas with aggressive mechanical ventilation. Over the ensuing decades, it became apparent that performing positive pressure ventilation worsened lung injury. The pivotal moment in the mechanical ventilation story would be the low versus high tidal volume trial. This trial shifted the focus away from normalizing gas exchange to reducing harm with mechanical ventilation. Further, it paved way for further trials testing ventilation interventions (PEEP strategy, prone position ventilation) and nonventilation interventions (neuromuscular blockade, corticosteroids, inhaled nitric oxide, extracorporeal gas exchange) in critically ill patients. That evidence-based intensive care medicine has undoubtedly had an influence on the outcome of critically ill patients, in general, and, particularly, of patients requiring mechanical ventilation. Temporal changes in mortality over the time have been scarcely reported for patients admitted to intensive care unit. Objective of this study is to estimate the changes over the time in several outcomes in the patients admitted to an 18-beds medical-surgical intensive care unit from 1991 (year of start of activity) to 2026

Sedation in ICU Patients With Mechanical Ventilation

Sedatives are the mostly common prescription for patients with mechanical ventilation due to the disease or therapies. Ciprofol is a new intravenous anesthetic agent transformed from propofol, and has a similar sedative effect of propofol in previous study. Whether ciprofol is safe and effective similar with propofol for sedation in ICU patients with mechanical ventilation? Therefor, a multi-center, double-blind, randomized control trial was conducted with a noninferiority design, to compared the rate of successful sedation without hypotension of sedation by ciprofol or propofol in ICU patients with mechanical ventilation. A Multi-Center, Double-Blind, Randomized Controlled Trial will be launched to evaluate the efficacy and safety of ciprofol versus propofol for sedation in ICU patients with mechanical ventilation.

KAP Asynchrony Survey

The investigators developed a web-based survey to assess knowledge, attitudes and practice of health care professionals about patient-ventilator asynchrony.

Telehealth-Enabled, Real-time Audit and Feedback for Clinician AdHerence (TEACH)

The purpose of this trial is to evaluate if augmenting a usual audit and feedback implementation approach with telehealth-enabled support improves coordinated spontaneous awakening/breathing trials and patient outcomes for mechanically ventilated patients.