Clinical Research Directory

Effectiveness of the Dynavision Device to Improve Spatial Awareness After Brain Injury

The purpose of this research is to determine the effectiveness of using the Dynavision D2 to improve left neglect in adults with brain injury, and improve performance of ADLs/IADLs. This study will use a randomized control trial at Providence Care Hospital in Kingston Ontario, with clients admitted to the Stroke and ABI services who have been identified through the Catherine Bergego Scale (CBS) as having moderate to severe left neglect. Individuals will be randomly assigned to the control arm, where they will get the usual 60 minutes of OT treatment daily or the intervention arm, which is 30 minutes of their usual OT treatment and a 30 minute session of the Dynavision for 10 sessions for short stay inpatients (\~ 3 weeks) and 20 sessions for clients with longer 5-6 week stay. The CBS will be used to measure change in neglect severity at three time points: baseline, following 10 sessions and following 20 sessions, for those that stay for longer.

Low-Field Bedside Brain Magnetic Resonance Imaging in Pediatric Extracorporeal Membrane Oxygenation

The primary object of the study is to further characterize safety and feasibility of low-field bedside MRI in pediatric and neonatal ECMO patients. To perform imaging assessments of an early-stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength. Collect qualitative data from the image assessments to optimize device performance using a low field magnetic resonance imaging device in a simulated use environment; Collect qualitative data from the image assessments using a high field magnetic resonance imaging, computed tomography and ultrasound devices. Generate anonymized image data for post-acquisition evaluation, performance measuring and planning for subsequent study size

Portable MRI for Pediatric Hypoxic Ischemic Brain Injury

This study will evaluate the sensitivity and specificity of low field portable MRI (pMRI) for detection of hypoxic ischemic brain injuries in pediatric patients compared to clinically obtained neuroimaging to define pediatric diagnostic limitations and to determine the diagnostic capabilities of this neuroimaging modality following optimization of image acquisition. The results of this study will help determine optimal clinical implementation opportunities in pediatric patients.

ECMO ABI Detection With Hyperfine

The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. The secondary objective is to describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients.

Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients

NUROPI is a single-centre, prospective, non-interventional study in the Intensive Care Unit (ICU) of Erasme Hospital (Hôpital Universitaire de Bruxelles, Brussels, Belgium). Some critically ill patients get worse during the first days of their ICU stay. Identifying them early could allow faster escalation of care. Nucleosomes are fragments of DNA wrapped around proteins called histones. They are released into the blood when cells die or when white blood cells form neutrophil extracellular traps (NETs). High blood levels of nucleosomes may reflect inflammation, clotting activation and organ damage. This study will measure the H3.1 nucleosome in the blood of 1,000 consecutive adult ICU patients. The measurement uses a CE-marked laboratory test (Nu.Q® NETs, chemiluminescence immunoassay on the IDS-i10 analyser). No additional blood sample is taken for the study. H3.1 is measured on the leftover plasma of blood samples already drawn for routine care, at ICU admission, 6 hours, day 1, day 3 and day 7. Patient treatment is not changed. Patients, or their relatives or legal representative, receive an information notice and may refuse participation at any time. The main question is whether H3.1, alone or combined with routine ICU data, can identify patients at high risk of clinical deterioration within 72 hours of ICU admission. Other questions concern the link between H3.1 and mortality, organ dysfunction, and ICU treatments, and how H3.1 levels change during the first week.

Comparison of Two Strategies for Endotracheal Tube Cuff Underinflation Prevention During Invasive Mechanical Ventilation

During invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (Pcuff) around 25 cmH2O is recommended for sealing the upper airways. The continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control.

High-Flow Nasal Cannula After Extubation in Acute Brain Injury

Patients with acute brain injury after neurosurgery are at increased risk of extubation failure after removal of the endotracheal tube. High-flow nasal cannula (HFNC) may provide better post-extubation respiratory support than conventional oxygen therapy (COT), but evidence in post-neurosurgical patients remains limited. This prospective observational study evaluated adult post-neurosurgical patients with acute brain injury who underwent planned extubation in the Surgical Intensive Care Unit of Bach Mai Hospital, Vietnam. Patients received either HFNC or COT after extubation according to routine clinical practice and the decision of the attending ICU physicians. The primary outcome was treatment failure, defined as reintubation or escalation of respiratory support within 5 days after extubation. Secondary outcomes included tracheostomy, ventilator-associated pneumonia, ICU length of stay, total duration of mechanical ventilation, and time from extubation to reintubation. Propensity score matching was used to reduce baseline imbalance between groups.

Weaning From Mechanical Ventilation in Patients With Acute Brain Injury

Acute brain injury (ABI) patients frequently necessate intubation and invasive mechanical ventilation (IMV). While some ABI patients are capable of breathing spontaneously, which is one of the main criteria of extubation and weaning. However, the rate of extubation failure was significantly higher in ABI patients compared with non-neurological critical care patients. In patients who have failed one or several trials of extubation, tracheostomy is recommend according to the latest ESICM consensus. Tracheostomy can enhance comfort, improve pulmonary hygiene and decrease sedation requirement, which could facilitate the liberation from ventilator. Numerous studies have explored the causes of weaning failure and provide various predictive models in guiding extubation and tracheostomy. Yet, due to limitations of such as small sample size or a lack of external validation, there is paucity of practical weaning algorithm tailored for ABI patients. The liberation from IMV in ABI patients still remains challenging with poor level of evidence in current guidelines or expert consensus. We aim to describe the weaning outcomes in ABI patients, and further investigate the potential predictors of weaning success in ABI patients.

PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury

This research is about whether treatment with a commonly used antibiotic can prevent infections in airway and lungs and improves the chance of surviving, if it is given soon after patients commence mechanical ventilation when they have been admitted to hospital with an acute severe brain injury. An acute severe brain injury can occur as a result of a stroke, a traumatic injury or due to lack of oxygen to the brain that happens as a result of a cardiac arrest. Patients who are unconscious after an acute severe brain injury often need assistance to breath adequately, and this assistance is given by a breathing tube, connected to a mechanical ventilator. This treatment is an emergency medical treatment. The breathing tube is inserted into the patients' airway by either their mouth or neck. For patients who need assistance with their breathing from a mechanical ventilator, infections in the airways and lungs, known as pneumonia, are a common complication. Everyone naturally has bacteria in their mouth, esophagus and stomach. Clinicians think that during the process of inserting the breathing tube, small amounts of these bacteria can be introduced into the airways and lung when people are unconscious following an acute severe brain injury, or during the process of placing the breathing tube into the airways. These bacteria are now in a place they aren't meant to be and can cause an infections in the airways and lungs known as pneumonia. The purpose of this research is to see if giving one dose of a common antibiotic can prevent patients developing pneumonia, which is associated with having a breathing tube inserted and being on a ventilator, improving the chance of recovery following the acute severe brain injury and ultimately improving the chance of surviving. When patients have a known infection, current guidelines are to treat them with antibiotics. Antibiotics work to kill the bacteria causing the infection. When a patient has an infection in their lungs, they often need to stay on the mechanical ventilator for longer. While current practice is to give patients with a proven infection in their airways and lungs (pneumonia) antibiotics, it is unknown if giving an antibiotic to patients to prevent these infections before they show signs of pneumonia may lead to better outcomes.

Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury

Acute brain injury (ABI) is a leading cause of death and long-term disability in children. Diagnosis depends on fast neuroimaging, and head computed tomography (CT) is the bedside reference standard despite exposing the developing brain to ionizing radiation. A safe, portable, radiation-free bedside tool is needed to help decide which children need a head CT, to speed CT when injury is present, and to safely monitor injured children between scans. This study evaluates B-mode cranial point-of-care ultrasound (cPOCUS) performed through the temporal (and frontal) bone windows in children undergoing a clinically indicated head CT in the pediatric emergency department (ED) and pediatric intensive care unit (PICU). Children's thin skulls provide adequate acoustic windows in more than 95% of cases. cPOCUS is acquired by trained research scanners within 6 hours of head CT and interpreted offline by two blinded expert readers; the radiology CT report is the diagnostic gold standard. This is a prospective observational study; cPOCUS results are not returned to the clinical team in real time and do not change clinical care.

Non-Invasive Triage for Intracranial Hypertension in Prehospital Care

This study tests whether two non-invasive tools can help paramedics detect dangerously high pressure inside the skull in patients with a sudden brain injury, such as stroke or head trauma, before they reach the hospital. The tools are a wearable sensor called Brain4care, placed on the head, and an ultrasound measurement of the eye's optic nerve. Neither tool requires needles, incisions, or any invasive procedure. The study has two parts. In the first part, researchers will use both tools on patients treated by the Mobile Emergency Care Service (SAMU) in Salvador, Brazil, to check how accurately the tools can detect high pressure inside the skull. The results from these tools will not be used to guide the patient's care during this part of the study. In the second part, some patients will be assessed using these tools as part of their emergency care, while other patients will receive standard emergency care. Researchers will compare how often each group of patients is correctly sent to a hospital with the specialized brain surgery services they may need. The goal of this research is to help emergency teams identify patients with dangerous brain pressure earlier and get them to the right hospital faster, which may improve their chances of recovery.

Brain Monitoring During PEEP-Based Respiratory Therapy in Critically Ill Patients

Mechanical ventilation is commonly used in critically ill patients with acute brain injury. Positive end-expiratory pressure (PEEP) and lung recruitment maneuvers are important ventilator strategies for improving oxygenation, but they may also influence cerebral blood flow, systemic hemodynamics, carbon dioxide levels, and brain electrical activity. The effects of PEEP-related ventilator changes on cortical function in neurocritical care patients remain insufficiently understood. This prospective observational physiological study will evaluate changes in brain electrical activity and cerebral blood flow during clinically indicated lung recruitment maneuvers and PEEP adjustments in mechanically ventilated neurocritical care patients. Multimodal monitoring will include electroencephalography (EEG), transcranial Doppler ultrasound, invasive arterial blood pressure, end-tidal carbon dioxide, and routine clinical variables. EEG-derived measures, including delta power ratio and related frequency-domain indicators, will be used to describe cortical activity. Cerebral blood flow velocity and low-frequency neurovascular coupling measures will be explored as secondary physiological outcomes. The study will examine whether PEEP-related changes are associated with alterations in EEG activity, cerebral blood flow, and neurovascular coupling, and whether these responses differ according to clinical status. The results may help improve understanding of brain-lung interactions during mechanical ventilation and inform future studies on individualized ventilation strategies in neurocritical care.

Effect of Central Venous Catheterization on Brain Pressure in Acute Brain Injury Patients

Acute brain injury (ABI) is a serious condition that can cause a dangerous increase in pressure inside the skull (called intracranial pressure, or ICP), which can harm the brain. Patients with ABI often need a central venous catheter (CVC) - a small, flexible tube placed into a large neck vein - to receive medications, fluids, and to monitor their circulation. However, placing this catheter might temporarily affect brain pressure, either because of the patient's head position during the procedure or the procedure itself. The effect size and duration are not yet known. The purpose of this observational study is to understand how placing a CVC in the neck (internal jugular vein) affects brain pressure in patients with acute brain injury. The study will closely monitor changes in brain pressure, blood flow, and oxygen levels in the brain during and immediately after the procedure. The study will also examine whether the brain's ability to regulate its own blood flow (called cerebral autoregulation) influences these changes. This prospective, observational study will enroll approximately 100-120 adult patients with ABI who are in the Intensive Care Unit (ICU) and need a CVC as part of their regular medical care. The study will be conducted in two large hospitals in China. There is no experimental treatment or intervention; only observation and data recording during the standard medical procedure will be performed. The main goal is to measure how brain pressure changes during CVC insertion. The study will also look at how long any changes last and whether the brain's blood flow regulation is affected. The results will help doctors better understand the risks of this common procedure and guide safer management of ABI patients in the ICU.

Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial

The LIMIT-TBI trial is a multicenter, international, randomized, phase II clinical trial designed to evaluate the feasibility and safety of targeting a neutral fluid balance compared to standard care in critically ill adult patients with traumatic brain injury (TBI). Fluid therapy is a cornerstone of TBI management, but optimal fluid balance remains uncertain, with both fluid overload and restriction potentially leading to adverse outcomes. This study aims to determine whether maintaining a daily fluid balance close to zero (±500 mL) during the first 5 days of ICU admission is achievable and safe. Participants will be randomized within 48 hours of ICU admission to either a protocolized neutral fluid balance strategy or standard care. Outcomes include feasibility of achieving the target balance, organ complications, hemodynamic parameters, ICU resource utilization, and mortality and neurological outcomes up to 6 months.

Physical Mobilisation to Acquired Brain Injury Patients in Intensive Care Units: a Prospective Cohort Study

The objective of this study is to quantify the amount of physical mobilisation provided to patients with moderate to severe acquired brain injury in Scandinavian neuro-ICs, and the association between intensity and duration of mobilisation, physiological data perceived to be related to the safety of high-level mobilisation, and amount of high-level mobilisation during the neuro-ICU stay.

Clinical Application of Low-Field Magnetic Resonance Imaging in Patients on Extracorporeal Cardiopulmonary Resuscitation

Timely identification of acute brain injury (ABI) patterns in patients with extracorporeal cardiopulmonary resuscitation (ECPR) is essential for prognostic assessment and optimization of clinical management, particularly anticoagulation strategies. This study aimed to evaluate the safety and feasibility of early 0.23-T MRI examination in ECPR patients. The investigators further assessed the image quality of the 0.23-T MRI and investigated the incidence and patterns of ABI, as well as their associations with neurological outcomes. This prospective observational study was conducted in the emergency intensive care unit (EICU) of Beijing Chaoyang Hospital, a high-volume ECPR center. The primary outcome was the feasibility of performing 0.23-T MRI in patients undergoing ECPR, defined as successful completion of the examination without serious adverse events (AEs).

Implementation of Neuro Lung Protective Ventilation

Patients who experience lung injury are often placed on a ventilator to help them heal; however, if the ventilator volume settings are too high, it can cause additional lung injury. It is proven that using lower ventilator volume settings improves outcomes. In patients with acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide in the arterial blood improves outcomes. Mechanical ventilator settings with higher volumes and higher breathing rates are sometimes required to maintain a normal partial pressure of carbon dioxide. These 2 goals of mechanical ventilation, using lower volumes to prevent additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both important for patients with acute brain injury. The investigators have designed a computerized ventilator protocol in iCentra that matches the current standard of care for mechanical ventilation of patients with acute brain injury by targeting a normal partial pressure of carbon dioxide with the lowest ventilator volume required. This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a standard of care mechanical ventilation protocol for patients with acute brain injury in the iCentra electronic medical record system at Intermountain Medical Center. We hypothesize that implementation of a standardized neuro lung protective ventilation protocol will be feasible, will achieve a target normal partial pressure of carbon dioxide, will decrease tidal volumes toward the target 6 mL/kg predicted body weight, and will improve outcomes.

Regional Ventilation Evaluation During Neuro-injury Weaning Study

This study evaluates changes in regional lung ventilation using thoracic electrical impedance tomography (EIT) during the weaning process from mechanical ventilation in ICU patients with acute brain injury. It aims to identify predictive EIT patterns related to extubation outcomes.

The Role of Transcutaneous Vagus Nerve Stimulation in Treatment of Acute Brain Injury

Acute brain injury is a major global health problem associated with high mortality and morbidity, limited therapeutic options, prolonged hospital stays, and long-term disability that significantly impairs quality of life and increases healthcare costs. Noninvasive transcutaneous VNS developed as a safer approach for treating cerebral edema, epileptic seizures, and blood-brain barrier disruption, for facilitating the recovery of motoric and cognitive functions, and for immunomodulation. Transcutaneous VNS improves cerebral perfusion pressure and tissue oxygenation, supports reperfusion of the penumbral zone, and reduces neuronal hyperexcitability, thereby suppressing seizures.It may exert anti-inflammatory effects by reducing microglial cytokine and chemokine production. Additionally, vagal stimulation promotes acetylcholine-mediated suppression of pro-inflammatory cytokines, including TNF, IL-1β, IL-6, and IL-18. Another anti-inflammatory mechanism involves ghrelin, a peptide hormone whose serum levels increase under vagal stimulation. Elevated ghrelin reduces TNF-α and other pro-inflammatory cytokines and may limit intracerebral hemorrhage by inhibiting the NLRP3 inflammasome and activating the Nrf2/ARE signaling pathway. Biomarkers such as S100 protein and neuron-specific enolase (NSE) are valuable indicators of brain tissue damage and clinical outcomes; tVNS may reduce their levels and support non-invasive monitoring of disease progression. The technique is considered safe in patients . To date, tVNS has not been evaluated in clinical trials in Croatia, nor reported in case studies or cohort analyses. Study outcomes will be correlated with patients' clinical status, duration and course of hospitalization, complication rates, and overall treatment outcomes.

VentricuLostomy AssoCiaTed InfeCtions (LACTIC): Focus on CSF Lactate and Sampling Site

This observational study involving patients with acute brain injury undergoing treatment with an external ventricular drain consists of three subprojects, aiming to: 1. investigate various biomarkers, with a primary focus on the development of cerebrospinal fluid lactate in relation to ventriculostomy-associated infection; 2. compare proximal and distal sample results obtained from an external ventricular drain; 3. describe the natural progression of various biomarkers in blood and cerebrospinal fluid following acute brain injury.

Contribution of Transthoracic and Transcranial Ultrasonography to the Titration of PEEP in Patients With ARDS and ABI

The present study will investigate whether the combined use of lung and brain ultrasonography is useful in selecting the optimal positive end-expiratory pressure in mechanically ventilated critically ill patients with acute respiratory distress syndrome and acute brain injury, aiming at an individualized, brain-protective ventilation strategy.

Brain-injured Patients Extubation Readiness Study

The BIPER study is a stepped wedge cluster randomised clinical trial aiming to decrease extubation failure in critically-ill brain-injured patients with residual impaired consciousness using a simple clinical score.

Multimodal Brain Monitoring as an Early Warning and Prognostic Tool for Acute Brain Injury

The primary aim of this study is to evaluate the effectiveness of multimodal brain monitoring technologies as both an early warning system and a prognostic tool in patients suffering from acute brain injuries. This research seeks to determine how effectively these tools can predict clinical outcomes and prevent complications by providing early alerts to healthcare professionals.

Connectivity and Neural Signatures of Consciousness in Unresponsive States

The CONSCIUS study is a prospective, interventional study including patients with acute brain injury and impaired consciousness implanted with intracranial electrodes. The aim of the study is to investigate seizures and thalamocortical neural dynamics underlying behavioral unresponsiveness.