Clinical Research Directory

Neuromuscular Electrical Stimulation in a Patient on Invasive Mechanical Ventilation (MOVCARE)

This clinical study aims to compare the effects of conventional physical therapy alone versus conventional physical therapy combined with neuromuscular electrical stimulation (NMES) in patients admitted to the ICU and undergoing invasive mechanical ventilation. Participants will be randomly assigned to receive either conventional physical therapy or the same therapy plus NMES applied to the lower limbs. The protocol includes muscle-specific stimulation parameters and safety criteria to postpone sessions in cases of clinical instability. The primary goal is to assess whether NMES improves muscle function and recovery in critically ill patients.

The Intensive Care Platform Trial

Among critically ill patients, many die, and many of the survivors and their family members struggle for years with reduced quality of life. Critically ill patients are treated in intensive care units (ICUs). Here, they receive life support, e.g., mechanical ventilation and advanced support of the circulation (heart and blood vessels) and kidneys. In addition, ICU patients receive many other treatments. It is, however, uncertain if all the treatments provide value for the patients. The desirable effects of many treatments are uncertain, and some may be wasteful or even harmful. Clinical trials are necessary to validly assess the desirable and undesirable effects of different treatments. However, conventional clinical trials have limitations: * They typically only assess a single question related to a single comparison of treatments at a time. * They are often not very flexible, including with regards to the number of participants needed, and this increases the risk that a trial will end up as inconclusive. * There is no or limited re-use or sharing of infrastructure across trials, leading to duplicate work and resource use. * Trial participants do usually not benefit from the obtained knowledge before the trial concludes. * Involvement of patients, family members, and other stakeholders is typically limited, which may decrease the relevance of the questions addressed. With the Intensive Care Platform Trial (INCEPT), we aim to tackle these challenges by establishing a flexible platform trial that continuously learns from the obtained results. The platform trial may run forever with simultaneous and continuous assessment of many treatments. INCEPT will continuously learn from the accrued data and use these to improve the treatment of both participating and future patients. With INCEPT, we are also building a framework for thorough and extensive involvement of key stakeholders, including patients and family members. INCEPT will improve the way clinical trials are done and increase the probabilities that treatments are improved. This will: * Directly improve outcomes for ICU patients. * Relieve a strained healthcare system by discarding inefficient or harmful treatments. * Ensure that new treatments are beneficial or cost-effective before implementation. * Lower the costs and burdens of assessing more treatments in the critically ill.

SOFA-2 Score in Turkish ICUs

This study aims to evaluate how well a new scoring system called the Sequential Organ Failure Assessment-2 (SOFA-2) works in adult intensive care units in Türkiye. SOFA-2 is designed to measure the severity of organ dysfunction in critically ill patients using routinely collected clinical and laboratory data. It is an updated version of the original SOFA score and reflects modern intensive care practices. In this multicenter observational study, adult patients admitted to participating intensive care units will be followed during their ICU stay. SOFA and SOFA-2 scores will be calculated during the first 24 hours of admission, and in patients with longer stays, additional scores will be recorded. No additional tests or treatments will be performed as part of the study. The main goal of the study is to examine the relationship between SOFA-2 scores and intensive care unit mortality. The results are expected to help clinicians better assess disease severity and outcomes in critically ill patients.

Comparison of Diaphragm Ultrasound and RSBI for Predicting Weaning Success in Mechanically Ventilated ICU Patients

The goal of this observational study is to evaluate the predictive value of diaphragmatic ultrasound compared to the Rapid Shallow Breathing Index (RSBI) in determining weaning success among mechanically ventilated patients in the ICU for more than 48 hours. The main question it aims to answer is: Which is more effective in predicting weaning success: diaphragmatic ultrasound (including Diaphragmatic Excursion \[DE\] and Diaphragm Thickening Fraction \[DTF\]) or RSBI, in patients ventilated \>48 hours in the ICU of Dr. Sardjito General Hospital, Yogyakarta? Participants will be adult ICU patients who are undergoing weaning from mechanical ventilation after more than 48 hours. Before extubation, each participant will undergo diaphragmatic ultrasound assessment to measure DE and DTF, along with RSBI measurement. The predictive accuracy of these parameters will be evaluated by comparing them with the actual weaning outcomes. Secondary objectives include: 1. Assessing whether diaphragmatic ultrasound is associated with a higher weaning success rate than RSBI. 2. Evaluating the correlation between DE values and successful weaning. 3. Determining the optimal cutoff values of DE and DTF as predictors of weaning failure. 4. Analyzing the incidence of weaning failure in patients who do not meet optimal diaphragm function criteria. 5. Identifying DE and DTF thresholds that may help reduce the risk of reintubation.

Adaptation and Validation of a Patient-centered Outcome Scale for People in the Intensive Care Unit (IPOS-ICU)

The focus of intensive care is on survival and the prolongation of life. The care of organ systems takes priority and is assessed through screening tools such as the Sequential Organ Failure Assessment (SOFA) score, which evaluates clinical and laboratory factors associated with prognosis. Despite advancements in modern intensive care, the hospital mortality rate for mechanically ventilated patients in 2022 was approximately 43%. Even for survivors of intensive care, post-intensive care syndrome poses a significant burden on quality of life. Although intensive care and palliative care often appear to be contradictory, clinical overlap between these populations is common, with both experiencing physical, psychosocial, and spiritual challenges that frequently require input from specialized teams. Nevertheless, palliative care remains underrepresented in German intensive care units (ICUs), with only 1.4% of ICU patients on prolonged mechanical ventilation receiving specialist palliative care. Therefore, the identification of patients in need of palliative care and the reduction of barriers such as limited resources and varying clinician attitudes must be addressed. This necessitates a robust tool for measuring and assessing palliative care needs specifically in ICU patients, enabling the implementation of interventions aimed at minimizing the burden on patients, families, and treating clinicians, as well as guiding appropriate allocation of healthcare resources. The Integrated Palliative Care Outcome Scale (IPOS) questionnaire was developed as a patient-centered measurement instrument from a palliative care perspective. IPOS enables the assessment of symptoms and needs from the viewpoint of patients and their families. For patients with COVID-19, an adapted version-IPOS-COV-was developed, wherein healthcare personnel assess patient symptoms and needs. However, no existing instrument comprehensively captures the physical, psychosocial, and spiritual needs of ICU patients and their families from a palliative care perspective. Such a tool could facilitate both the identification of patients requiring palliative care and serve as an endpoint for evaluating the effectiveness of palliative care interventions in ICU settings, including post-discharge outcomes related to post-intensive care syndrome affecting both patients and families. The underlying hypothesis is that a patient-centered measurement instrument addressing physical, psychosocial, and spiritual needs from a palliative care perspective for ICU patients can be developed and validated based on the IPOS. Additionally, demographic data, clinical course, ICU interventions (e.g., mechanical ventilation, dialysis, palliative care consultations, family discussions, and therapy goal limitations), as well as SOFA scores and Palliative Phase of Illness (PPoI) classifications at the time of IPOS-ICU assessment, will be collected. It is hypothesized that IPOS-ICU scores will correlate with disease severity (as measured by SOFA and PPoI) and poor ICU outcomes, including length of stay, mortality, and discharge location. Furthermore, it is hypothesized that interventions such as palliative care consultations will be associated with lower IPOS-ICU scores. In the first phase of the study, an international and multiprofessional expert panel with experience in both intensive and palliative care will adapt the IPOS questionnaire for ICU patients, resulting in the development of the IPOS-ICU. The following modification strategies will be applied: rewording, removal, addition of items, adjustment of recall periods, and inclusion of a "cannot assess" response option. Online meetings will be conducted with representatives from Germany, Switzerland, the United Kingdom, the Czech Republic, and the United States. A larger review team will then evaluate the adapted version, and an informal "comfort consultation" will be conducted in ICU settings to ensure that the IPOS-ICU is considered appropriate and acceptable by ICU staff. Following adaptation, the validation phase will be conducted using a multicenter design. After obtaining informed consent from study participants, the IPOS-ICU will be administered at designated time points identified during the adaptation process. ICU staff (including at least one nursing professional and one medical professional) will complete the IPOS-ICU. The questionnaire will include an assessment of the PPoI (categorized as stable, unstable, deteriorating, dying, or deceased), and a free-text field for recording the estimated number of hours spent with the patient. Electronic Case Report Forms will capture demographic data, SOFA scores, treatment details, and outcomes following ICU discharge, all extracted from medical records. This study holds significant relevance by addressing the gap between the identification of palliative care needs and the actual implementation and evaluation of palliative care in ICU settings.

Effect of Abdominal Massage on Patients in Intensive Care Unit

Bowel motility can be affected by many factors such as immobilization, lack of fiber in the nutritional formula, inadequate fluid intake, and lack of privacy for toileting in patients hospitalized in the intensive care unit. Abdominal massage, which is one of the effective methods to increase intestinal motility, is accepted as an intervention that can be safely applied in patients. The aim of our study was to investigate the effect of abdominal massage applied to patients hospitalized in the intensive care unit on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use. Hypotheses H0: Abdominal massage application has no effect on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use in patients hospitalized in intensive care unit. H1: Abdominal massage application has an effect on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use in patients hospitalized in intensive care unit. In this randomized controlled study, the data of patients who received abdominal massage for 5 days during routine physiotherapy applications and those who did not will be recorded. Randomization will be performed in a 1:1 ratio using a computer generated randomization schedule. The effect of abdominal massage on sepsis, survival, discharge time from intensive care, amount and duration of antibiotic use will be examined by using the data of 2 groups with and without abdominal massage in a randomized controlled trial.

Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients

Intensive Care Unit Acquired Weakness (ICU-AW) is a common complication of critical illnesses, occurring in approximately 50% of ICU patients and is strongly associated with increased morbidity, physical impairments, and both short- and long-term mortality. The main characteristics of ICU-AW are symmetrical generalised muscle weakness affecting both respiratory and limb muscles; however, the clinical phenotype may differ depending on age, disease burden, length of ICU stay, and mechanical ventilation duration. The objective of the present study is to evaluate the feasibility achieved and the safety outcomes reported in a cohort of critically ill patients who undergo early mobilisation and rehabilitation in intensive care units. This research is a multicentre prospective cohort study.