A Trial of Enteral Colostrum on Intestinal Permeability in Critically Ill Patients
Critical IllnessThe effects of colostrum on intestinal permeability in critical ill patients has not been investigated. In current trial, intensive care unit patients with enteral feeding will receive either enteral colostrum or maltodextrin as placebo.
Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients
Critical IllnessEnteral Nutrition1 moreGlutamine-induced recovery in intestinal barrier function by reducing bacterial translocation was demonstrated in previous studies. In this trial, intensive care unit patients with enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 10 days and the effects of the intervention on intestinal permeability will be assessed.
Diaphragm Protective Ventilation in the Intensive Care Unit
Critical IllnessMuscle Weakness5 moreDue to an accident, pneumonia or surgery, patients can have severe shortness of breath or lung damage to such an extent that it compromises vital functions. At such times, mechanical ventilation can be lifesaving. The ventilator temporarily takes over the function of the respiratory muscles to ensure adequate uptake of oxygen and removal of carbon dioxide. Mechanical ventilation can usually be stopped quickly after the initial disease has been treated. Unfortunately, in up to 25-40% of ventilated patients it takes several days to weeks before mechanical ventilation can be discontinued, even after treatment of the initial disease. This phenomenon is termed weaning failure. Weakness of the respiratory muscles, such as the diaphragm, is one of the leading causes of weaning failure. Like other skeletal muscles, the diaphragm can become weakened if it is used too little. This happens often during mechanical ventilation because of excessive assistance provided by the ventilator or use of sedative medication. Excessive activity of the diaphragm can also lead to damage and weakness, just like in other muscles that have to perform excessive amounts for a prolonged period of time. Additionally, excessive work by the diaphragm might have a direct damaging effect on the lungs, which leads to a vicious cycle. As such, it is very important to find a balance between resting the diaphragm (which may lead to weakness) and placing excessive work on the diaphragm (which can damage the diaphragm and possibly the lungs). In this study, the investigators want to test whether insufficient activity and excessive activity of the diaphragm during mechanical ventilation can be prevented or reduced. The investigators plan to measure the diaphragm activity in 40 participants on mechanical ventilation. Participants will be randomly assigned to the intervention group or the control group. In the intervention group, ventilator support levels will be adjusted according to the observed diaphragm activity, in an attempt to ensure adequate diaphragm activity. The control group receives usual care. The hypothesis is that adjusting the level of support provided by the ventilator is a feasible method to improve the time that the diaphragm operates within acceptable levels of activity over a 24 hour period.
Responsiveness Index Versus the RASS Based Method for Adjusting Sedation in Critically Ill Patients...
Critical IllnessSystematic evaluation of pain, agitation and delirium in ICU-patients is recommended and deep sedation should be avoided. Sedation is still monitored with clinical assessments, like RASS. The Responsiveness Index (RI) is a recently described method for ICU sedation monitoring. It is based on processed frontal EMG and reflects the interaction between a patient's conscious state and the intensity and frequency of stimulations during treatment. RI has not been randomly compared to RASS to titrate sedation to target at a clinically adequate sedation state. In this open randomized controlled pilot study of 32 critically ill, mechanically ventilated adult patients, investigators will evaluate the feasibility, safety and efficacy of RI based sedation compared to standard RASS based titration of sedation. Investigators hypothesize first that RI controlled sedation will be safe and, second that RI controlled sedation will associate with increased number of ventilator free days alive in 30 days without excess adverse events.
Efficacy of a Sleep Hygiene Toolkit for Patients in ARU
Sleep DisturbanceSleep Disorder2 moreSleep Hygiene Study Abstract: INTRODUCTION Sleep is integral to the health of a person and can have multifaceted contributions to a person including their physical, cognitive, and psychosocial well-being. However, within a recent survey evaluating the sleep perception of patients within an acute rehabilitation unit (ARU), there was a high prevalence of reported sleep disturbances and poor sleep hygiene compared to at home (Davis et al., 2021). In addition, patients within an ARU generally have an extended length of stay-which could mean many nights of poor sleep hygiene. Given the importance of sleep in facilitating a person's health and recovery versus the challenges the hospital environment poses on patient's sleep hygiene, this study aims to examine the efficacy of a sleep hygiene toolkit provided to the patients admitted to ARU. The sleep hygiene toolkit includes multiple non-pharmaceutical resources addressing sensory stimulation and psychological and emotional needs. OBJECTIVE This study aims to evaluate the perception of sleep quality experienced by ARU patients utilizing the sleep hygiene toolkit. This study hypothesizes that with the use of a sleep hygiene toolkit, patients will report a positive impact on their sleep quality during their hospital stay. METHODOLOGY This is a within-subjects study design. All eligible participants will be given the sleep hygiene intervention administered for a period of five days. The sleep hygiene toolkit includes multiple resources including assistive devices (ie. eye masks and ear plugs), sensory-based tools (ie. aromatherapy, music, meditation, and breathing techniques), cognitive behavioral therapy (CBT) activities (ie. addressing anxiety and worry), and education and training on sleep hygiene. The visual analog scales on the Richards-Campbell Sleep Questionnaire will be used to assess patient's overall sleep perception pre- and post-intervention. CONCLUSION Given this prevalent area of need for patients admitted to ARU, occupational therapists (OT) can offer an additional way to address it. According to the Occupational Therapy Practice Framework (2020), OTs are well-equipped to provide comprehensive treatment to promote a person's sleep preparation and sleep participation. The results will determine the efficacy of a sleep hygiene toolkit for ARU patients in addressing their sleep needs-an important component in a patient's health and recovery during their hospital stay. SIGNIFICANCE OF TOPIC This study aims to highlight the barriers to successful participation in the occupation of sleep and rest for patients admitted to an acute rehabilitation unit (ARU). The creation of this sleep hygiene toolkit is to address a person's sleep preparation and sleep participation. Although sleep quality and its impact are a topic well studied, there is limited study on occupational therapy led interventions aimed to benefit the patient's sleep quality in an ARU setting.
Echocardiographic Evaluation of RV Injury in the ICU
Right Heart FailureUnspecified4 moreThe adequate characterization of RV injury is currently unknown. The hypothesis is that the best characterization of RV injury is the one with the most significant impact on the response to fluids and on the outcome. An RV failure is expected to induce fluid-unresponsiveness and potentially worst outcome. The main objective is to characterize different types of RV injury in critically ill patients by examining their association, including predictive performances, in hemodynamics parameters, ventilation parameters, and clinical outcomes The study will be based on the realisation of an echocardiography within 48 hours following inclusion.
Comparison of Clinical Outcome Among Vaccinated and Unvaccinated Coronavirus Disease Patients in...
Coronavirus InfectionsCritical IllnessCorona virus disease has been a pandemic since its beginning. The problem has scaled to break health care system of multiple countries. One of the prime strategy of preventing this disease has been large mass scale vaccination campaign ongoing worldwide. No vaccine has been proven to 100 percent effective in preventing the infection with coronavirus disease so far. The investigators are conducting a study comparing outcome among vaccinated and unvaccinated population admitted to critical care unit of civil services hospital, Kathmandu , Nepal .
The Nociception Level (NOL) Index for Pain Assessment in the Adult Intensive Care Unit
PainAcute3 moreAssessing pain in the adult intensive care unit (ICU) is challenging because many patients are unable to communicate due to mechanical ventilation and sedation. Therefore, it is necessary to have alternative methods to assess pain in this vulnerable patient population. In this project, the use of a multi-parameter technology (i.e., the Nociception Level (NOL) index) will be tested for pain assessment in ICU adults. The NOL index is a value from 0 to 100 obtained by calculating different parameters (e.g., pulse, skin temperature) captured through a small probe placed on the patient's finger. The NOL was initially developed for assessing nociception, pain and analgesia in anesthetized patients undergoing surgery, and its use in the ICU is new. The NOL's use before, during and after standard care procedures known to be painful (e.g., tube or drain removal, suctioning of secretions through the endotracheal tube) and non-painful (e.g., cuff inflation to measure blood pressure, soft touch) in ICU adults. The NOL will be monitored in three groups: a) patients able to communicate so they can self-report their pain (gold standard criterion) and express behaviors, b) patients unable to communicate but express behaviors (reference criterion), and c) patients unable to communicate and to express behaviors. In the first group, patients will be asked to self-report their pain and procedural distress on a 0 to 10 scale. In the first and second group, patients will be assessed for pain using a standardized behavioral scale which will be completed by trained research staff. In the third group, only the NOL will be monitored. Analgesic and sedative medication administered to patients will also be documented from medical charts. The ability of the NOL to detect pain based on self-reports of pain and behavioral scores, and its ability to discriminate between painful and non-painful procedures will be examined. If found to be useful, the NOL could be used as an alternative measure of pain and improve its recognition and treatment in vulnerable ICU patients.
Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters...
Critical IllnessPain is common in intensive care and gives rise to multiple consequences that can impact the future of patients. The placement of deep venous catheters are painful gestures of common practice in intensive care. However, some patients are ventilated and sedated and their level of pain is difficult to judge. Quantitative pupillometry seems to be a reliable tool for assessing pain in these patients unable to communicate. The method is already common practice in the operating room for this indication and recent studies increasingly validate its use in intensive care. The aim of the study is to validate the different levels of pain that can be assessed by pupillometry within this population during catheterization and to identify any non-responding subgroups (in order to conduct future clinical trials evaluating pain therapies).
Intravenously Administered M6229 in Critically Ill Sepsis Patients
SepsisSeptic Shock1 moreSepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Mortality is high and survivors frequently suffer from long-term sequelae. Extracellular histones have been identified as essential mediators in the pathogenesis of sepsis and septic shock. These toxic molecules are released by damaged cells in response to infection and high extracellular levels can induce tissue injury and multiple organ dysfunction syndrome. Extracellular histones can be neutralized by complexation with the new candidate drug called M6229, a non-anticoagulant heparin, allowing the use of elevated dose levels relative to regular unfractionated heparin. This project aims at the roll-out of a first-in-man clinical study in sepsis patients evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effects of intravenously administered M6229 in subjects suffering from sepsis.