Clinical Research Directory

Behavioral Economic & Staffing Strategies in the ICU

The overarching goal of this study is to support the "real world" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Investigators will specifically evaluate two discrete strategies grounded in behavioral economic and implementation science theory (i.e., real-time audit and feedback and registered nurse implementation facilitation) to increase adoption of the ABCDEF bundle in critically ill adults.

Diaphragm Atrophy and Dysfunction in Mechanical Ventilation

The gold standard of twitch transdiaphragmatic pressure recordings would ultimately clear the fog around the rate of development of Ventilator induced Diaphragm Dysfunction (VIDD) in mechanically ventilated patients over time. Through measurements made even after mechanical ventilation (MV) it could be clarified to what extent patients recover from VIDD. Paired with cortical stimulation and electromyographic recordings of diaphragm muscle potentials, it could be explored to what extent decreased diaphragm excitability due to long term MV contributes to VIDD on the level of motor cortex. Against that background the present project aims at determining the rate of decline in diaphragm function, strength and control in patients undergoing MV (including measurements after extubation).

Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation

The TEMA study (Targeting prEssure-Muscle-index to avoid ventilatory over-Assistance during pressure support ventilation) is a prospective, interventional crossover trial investigating the relationship between pressure support (PS) and tidal volume (Vt) in ICU patients with acute hypoxemic respiratory failure (AHRF) receiving pressure support ventilation (PSV). The study aims to assess whether the Pressure-Muscle Index (PMI)-a marker derived from the difference between plateau and peak inspiratory pressure-can help identify the optimal level of ventilatory assistance, preventing over-assistance and its associated complications such as diaphragm atrophy and patient self-inflicted lung injury (P-SILI). By exploring the sigmoidal relationship between PS and Vt, the study seeks to define a physiological threshold (PMI=0) that may serve as a personalized target for PSV titration.

Ventilator-based Inspiratory Muscle Training for Patients With Respiratory Failure

This study will be conducted to compare the effectiveness of progressive inspiratory flow trigger sensitivity rising versus stepwise pressure support reduction as ventilator-based inspiratory muscle training methods on weaning and extubation success in mechanically ventilated patients with respiratory failure.

Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients

A multi-center, prospective, randomized, double-blind, no-inferiority clinical trial designed to assess the the safety and efficacy of remazolam besylate in sedation of critically ill mechanically ventilated patients after surgery compared to dexmedetomidine.

Nebulized Furosemide, Heparin, Hypertonic Saline in Mechanically Ventilated Acute Respiratory Distress Syndrome Adult Patients

There are no specific drugs or therapies available to directly treat/prevent ARDS. Mechanical ventilation with an aim to minimize Ventilator Induced Lung Injury (VILI) and management of refractory hypoxemia are the keystones in supportive management of ARDS.

ClusterVAP: Multicentre Proteomic Endotyping of Ventilator-associated Pneumonia

Ventilator-associated pneumonia (VAP) is a common and serious infection in patients receiving mechanical ventilation in intensive care units. Current diagnostic methods are imprecise, leading to unnecessary antibiotic use and delayed treatment. The ClusterVAP study aims to identify biologically and clinically distinct subgroups of patients with suspected VAP by analyzing proteins in bronchoalveolar lavage (BAL) fluid using advanced proteomic techniques. This multicentre observational study will enroll approximately 400 adult patients from intensive care units in Sweden, France, Portugal, Denmark, and the United Kingdom. BAL or mini-BAL samples collected for clinical reasons will be analyzed to define "pneumoclusters" and explore their association with patient outcomes. The study will also identify candidate biomarkers that could support future diagnostic tools. No experimental treatments are given; all patients receive standard care. Results may improve diagnostic accuracy and guide personalized treatment strategies for critically ill patients.

The Effects of VC Versus PC Ventilation on Cerebral and Respiratory Parameters in Patients Undergoing Laparoscopic Gynecologic Surgery

The aim of the study was to determine whether the use of different mechanical ventilation modes in patients with Trendelenburg position and CO2 insufflation affects respiration and cerebral oxygenation due to postoperative atelectasis, and was to determine whether there was any hemodynamic effect.

EIT-guided PEEP Titration Versus Standard Ventilation in Bariatric Surgery

This study is a prospective, single-center, single-blind, randomized controlled clinical trial. Patients scheduled for laparoscopic bariatric surgery will be selected and randomly assigned to either the EIT-guided individualized PEEP group (Group P-eit) or the control group (Group P-8). Group P will be ventilated using the PEEP value determined by EIT, while Group C will be ventilated with a fixed PEEP value of 8 cmH2O.The primary outcome is the incidence of postoperative pulmonary complications (PPCs) within 72 hours after surgery.

CT for Personalized Mechanical Ventilation

The goal of this study is to compare two different ways of helping patients with a condition called sepsis who need help breathing using a machine called a ventilator. The investigators want to study which way of setting the ventilator is better for the lungs. Here are the main questions the investigators want to answer: 1. How does the amount of air in the lungs and the way it moves differ between the two ways? 2. How does the way air spreads out in different parts of the lungs differ between the two ways? In this study, the investigators will take special pictures of the lungs using a machine called a CT scan. The pictures will show us how much the lungs stretch and how much air is in different parts of the lungs. The investigators will compare two different ways of using the ventilator: one personalized for each patient based on their breathing, and another way that is commonly used. By comparing these two ways, the investigators hope to learn which one is better for helping patients with sepsis who need the ventilator. This information can help doctors make better decisions about how to care for these patients and improve their breathing.

Prevalence of Pain in Mechanically Ventilated Patients in Intensive Care Units

Introduction: Pain is a subjective symptom, a physiological response that is difficult to assess, which affects the body physically and/or emotionally. It is a common phenomenon among clinical and surgical patients in Intensive Care Units (ICU). And its effects are the combined results of physiological and behavioral aggressions caused by clinical conditions, immobility and the execution of common procedures in ICU's. The presence of pain appears to be independently associated with worse clinical outcomes, including higher infection rates, patient-ventilator asynchronies, delirium, prolonged mechanical ventilation (MV), length of hospital stay and higher healthcare costs. Objectives: To evaluate the prevalence of pain and its associated factors in mechanically ventilated surgical patients in ICU's. Methods: This is a cohort, prospective, multicenter study designed to estimate the prevalence of pain, its intensity, its associated factors, correlating them to outcomes such as patient-ventilator asynchrony rate, time to weaning, and 28-day mortality in mechanically ventilated patients. All research participants who meet the inclusion criteria and who are not using neuromuscular blockers, or have any other condition associated with altered pain perception, will be evaluated using the Behavioral Pain Scale (BPS) and the Critical Care Pain Observation Tool (CPOT) on the 2nd day of mechanical ventilation and on the first day of awakening, when the RASS scale is between 4 and -2. At the same time, data will be collected on the ongoing sedoanalegesia strategy, and the asynchrony index will be calculated \[(Nº of asynchronous ventilatory cycles/Nº of ventilatory cycles studied) \*100\]. The end point of the research will be 28 days, where the time until weaning, time until discharge or death will be established using the Kaplan-Meier estimators. Expected results: The prevalence of pain and its intensity is associated with the presence of patient-ventilator asynchronies and thus with harsh outcomes related to the length of stay in the ICU, time until weaning and thirty-day mortality in the ICU. It is estimated that there is agreement between the BPS and CPOT scales in mechanically ventilated patients.

A New Ultrasonographic Tool to Assess Pulmonary Strain in the ICU

The primary objective of the study is to create a small dataset of regional pulmonary strain values in patients suffering from pulmonary diseases under mechanical ventilation in an intensive care setting. Hypothesis: The analysis of lung ultrasonographic sequences using speckle-tracking allows the determination of local pleural strain in 4 predetermined pulmonary areas in mechanically ventilated patients suffering from pulmonary diseases.

VentilO Prospective Study

This is a randomized, open-label study comparing intial settings made by clinicians with settings recommandation made by the VentilO application immediately after intensive care unit admission.The study will allow direct comparison of the frequency of acidosis when patients are ventilated using the parameters of the VentilO application versus parameters chosen by the clinician. The variables determined by the clinician or VentilO will be respiratory rate, tidal volume and resulting minute ventilation.

Potential Impact of the Use of the Application VentilO

Mechanical ventilation is a vital support associated with the treatment of patients with acute respiratory failure and in other indications such as surgery under general anesthesia, coma or shock. Optimization of settings during mechanical ventilation and implementation of protective ventilation help to avoid ventilation-induced injury, ensure adequate oxygenation and maintain adequate carbon dioxide concentration to avoid respiratory acidosis or alkalosis. Similarly, there is also no clear recommendation, to our knowledge, for the initial setting of the respiratory rate. Therefore, initial settings are not always adequate and in the literature the frequency of respiratory acidosis is very high, reaching about half of the patients receiving mechanical ventilation. VentilO, is an application that is available on smart phones. This educational application provides clinicians with initial settings and optimization of these settings based on gender, height, weight, body temperature and patient type. The algorithm used is based on published data regarding ventilatory requirements in different populations and the anatomical and instrumental dead space of patients. The purpose of our study is to: 1. Assess whether ventilatory settings after intubation are appropriate. 2. To compare the ventilatory adjustments made by clinicians with those proposed by the VentilO appalication.

Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a Pilot Study

We propose a randomized pilot/feasibility study comparing oral care treatment as usual (TAU) with Swiftsure SwishKit plus oral care TAU on the presence and magnitude of bacterial load in the oropharyngeal space in orotracheally intubated patients. The trial will be conducted with IRB approval and written consent from patient or its legal representative.

Early Diagnosis of ARDS in Mechanically Ventilated Patient Using LUS Score in Comparison With CT

The aim of this study is to assess accuracy of Lung ultrasound score for early diagnosis of acute respiratory distress syndrome in patients who expected to be mechanically ventilated more than 24 hour in comparison with computed tomography chest .

Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy

The objective of the study is to determine how controlled mode ventilation and support mode ventilation impact ventilator-free days and diaphragmatic atrophy.

Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation

Retention of airway secretions is a frequent complication in critically ill patients requiring invasive mechanical ventilation (MV).This complication is often due to excessive secretion production and ineffective secretion clearance. Mechanical insufflator-exsufflator (MI-E) is a respiratory physiotherapy technique that aims to assist or simulate a normal cough by using an electro-mechanical dedicated device. A positive airway pressure is delivered to the airways, in order to hyperinflate the lungs, followed by a rapid change to negative pressure that promotes a rapid exhalation and enhances peak expiratory flows. However, there is no consensus on the best MI-E settings to facilitate secretion clearance in these patients. Inspiratory and expiratory pressures of ±40 cmH2O and inspiratory-expiratory time of 3 and 2 seconds, respectively, are often used as a standard for MI-E programming in the daily routine practice, but recent laboratory studies have shown significant benefits when MI-E setting is optimized to promote an expiratory flow bias. The investigators designed this study to compare the effects of MI-E with an optimized setting versus a standard setting on the wet volume of suctioned sputum in intubated critically ill patients on invasive MV for more than 48 hours.

The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial

This clinical trial aims to assess the efficacy of sedation protocol targeting optimal respiratory drive using P0.1 and arousal level compared with conventional sedation strategy (targeting arousal level alone) in patients requiring mechanical ventilation in the medical intensive care unit.

Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia

Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.

The Caffeine Therapy in the Fetal to Neonatal Transition

Introduction: The caffeine is used in the treatment for apnea of prematurity and it has several positive effects in the neurodevelopment of preterm babies. There are innumerable observational studies suggesting that initiating caffeine in the first hours of life may offer more benefits in the reduction of the necessity of intubation and in ventilation time. It is necessary to expand further research on the best time to start caffeine, which may improve the quality of care for premature infants. Objective: To evaluate the benefits of caffeine administration in the first two hours of life compared to administration at 24 hours of life in premature patients on noninvasive mechanical ventilation with birth weights less than 1250 grams. Methodology: Preterm newborn patients with birth weight \< 1250 grams born at Hospital de Clínicas de Porto Alegre who are not intubated in the delivery room will be included. Patients will be randomized into two groups. One arm of the study will receive caffeine at 2 hours of age and the other arm will receive caffeine at 24 hours of age (control). Patients in the control group will receive 0.9% SF at 2 hours of life in order to keep the study blinded. The following outcomes will be evaluated: need for intubation, time on invasive and non-invasive mechanical ventilation, BPD, necrotizing enterocolitis, need for ROP treatment, PDA with hemodynamic repercussions, peri-intraventricular hemorrhage, leukomalacia and death. The sample size calculation is 50 patients, 25 in each arm. Expected Results: It is expected to find a 43% reduction in the need for intubation in preterm infants who receive caffeine in the first two hours of life compared to administration at 24 hours of life. It is also expected to find a reduction in mechanical ventilation time, in addition to a possible reduction in negative outcomes associated with prematurity.

Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection

Multicenter, randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU. Lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes. Current specific treatment consists of intravenous antibiotics. The current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized HS has additional benefits, like loosening of secretions, eradicating bacteria or reducing inflammation.

How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children

The objective is to compare the impact of early mobilization and routine care on diaphragm thickness in critically ill children

NMES Role to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines.

Particularly, muscle respiratory wasting will occur early (18 to 69 hours) in up to 60% of patients with mechanical ventilation (MV), leading rapidly to diaphragmatic weakness, which is associated with prolonged MV use, longer ICU and hospital stay, and higher mortality risk. Sepsis and muscle inactivity, derived from sedation and MV use, are key driver mechanisms for developing these consequences, which can be avoided through early physical activation. However, exercise is limited at the early stages of care, where sedation and MV are needed, delaying muscle activation. Neuromuscular electrical stimulation (NMES) represents an alternative to achieve early muscle contraction in non-cooperative patients, being able to prevent local muscle wasting and, according to some reports, has the potential to shorten the time on MV, suggesting a systemic effect through myokines, a diverse range of cytokines and chemokines secreted by myocytes during muscle contraction. However, no studies have evaluated whether NMES applied to peripheral muscles can exert distant muscle effects over the diaphragm, ameliorating its weakness and if this protective profile is associated with myokine's change in ICU patients. This proposal comprises a randomized controlled study of NMES applied twice daily, for three days, compared to standard care (no NMES). Thirty-two patients will be recruited in the first 48 hours after MV and randomly assigned to the control group or NMES group (16 subjects each). Muscle characterization of quadriceps and diaphragm will be performed at baseline (Day 1, before the first NMES session) and after the last NMES session (morning of day 4). Myokine measurements \[IL-1, IL-6, IL-15, Brain-Derived Neurotrophic Factor (BDNF), Myostatin and Decorin\], through blood serum obtained from peripheric blood samples, will be performed just before starting NMES (T0) at the end of the session (T0.5), and 2 and 6 hours later (T2 and T6). These myokine curves will be repeated on days 1 and 3 at the first NMES session of the day. The Control group will be assessed in the same way and timing, except that blood samples will be at T0 and T6. Additionally, functional outcomes such as MV time and ICU length of stay will be registered for all patients at ICU discharge. Standard care won´t be altered.