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Critical Illness clinical trials

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NCT ID: NCT06294158 Not yet recruiting - Critical Illness Clinical Trials

Light and Noise: Objectively Assessing Environmental Risk Factors for Delirium in the ICU

LANYARD-ICU
Start date: April 2024
Phase:
Study type: Observational

Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in critically ill patients, is a relatively recent development. However, research into delirium prevention and treatment is now in focus of scientific efforts internationally. Knowledge of intensive care unit (ICU) environment as a potential modifiable risk factor for delirium is insufficient to this date. This study thus seeks to evaluate, whether potentially modifiable environmental factors, such as noise or dazzling, are associated with development of delirium. Knowledge derived from this investigation could change both the process of care provision in intensive care units as well as the design of ICUs in general in the future. This project is planned to be carried out as an observational pilot study at three perioperative ICUs at the University Medical Centre Graz. Adult patients shall be screened for inclusion, if not deeply sedated. Suitable patients shall be included into the study after written informed consent or deferred consent if they can be expected to remain in the ICU for at least another two days, if they are not already in delirium, if the ICU environment is not actively modified for therapeutic reasons and if no treatment limitations are in place. Over a study duration of one year, 250 to 300 patients are expected to be enrolled into the study. Of those, 60 to 120 patients are likely to develop delirium. Baseline data known to be of relevance for outcome prediction in critically ill patients and factors known to predispose for development of delirium during ICU and hospital stay will be collected. Study equipment will be deployed to measure noise levels and illumination repeatedly over the day. Daily assessments for delirium using the Confusion Assessment Method in Intensive Care Units (CAM-ICU) will be performed. Vital status, physiologic parameters and parameters of ongoing treatment will concomitantly be documented on a daily basis. Data on light and noise levels are then to be unified with parameters of physiology and treatment, vital status, and results of daily assessments for delirium. Statistical analysis using methods of descriptive and comparative statistics as well as both unadjusted and adjusted logistic regression analysis will be performed to identify factors significantly associated with the development of delirium (i.e., risk factors).

NCT ID: NCT06288724 Not yet recruiting - Critical Illness Clinical Trials

MOdifiable facTors to Improve VentilAtion ThErapy in ICU

MOTIVATE-ICU
Start date: March 2024
Phase:
Study type: Observational [Patient Registry]

ABSTRACT Introduction: Invasively ventilated patients in low and middle-income countries (LMICs) experience significantly higher mortality compared to those in High income countries (HICs). Direct application of HIC strategies to LMICs maybe ineffective due to context-specific challenges. This study aims to leverage the Intensive Care Registry of Uganda (ICRU) to identify ICU structural and process-related modifiable factors that impact patient outcomes in a low income country. Methods: The MOTIVATE-ICU is a prospective multicentre observational study in invasively ventilated patients. It involves a registry-embedded component examining patient- and process-related factors and a cross-sectional survey on ICU organizational structures. Inclusion criteria encompass patients aged ≥ 15 years undergoing IMV in Ugandan ICUs. Primary outcomes are ICU mortality, ICU length of stay (LOS), and duration of ventilation. Secondary outcomes include ventilator-associated complications, non-pulmonary organ support. tTracheostomy outcomes will be explored in a pre-planned substudy. Factors potentially associated with outcomes will be categorized into two groups; non-modifiable factors and potentially modifiable. Non-modifiable factors will include patient-related factors like age, comorbidities and illness severity; potentially modifiable factors include processes of care (e.g. sedation levels) and ICU organizational structure (e.g. staffing patterns). Multilevel multivariable logistic regression will be utilized to study associations, with both patient and ICU level fixed effects considered. Ethics and Dissemination: Given its observational nature, this study seeks a waiver for patient individual informed consent. Data anonymization ensures patient privacy. Following the principles of the Declaration of Helsinki, relevant ethical approvals will be acquired. Study findings will be disseminated through conferences and peer-reviewed journals.

NCT ID: NCT06285162 Not yet recruiting - Critically Ill Clinical Trials

Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy

UFANI
Start date: April 2024
Phase:
Study type: Observational

The Analgesia Nociception Index (ANI) reflects the balance between sympathetic and parasympathetic tone. It is based on a specific interpretation of the R-R interval variation. During fluid removal by net ultrafiltration in patients with fluid overload and continuous renal replacement therapy, some data suggest that haemodynamic variation could be induced by the autonomic nervous system. The study aims to investigate ANI variations in this context and their association with the haemodynamic variations observed.

NCT ID: NCT06281743 Not yet recruiting - Critical Illness Clinical Trials

Attitudes to Decisions to Withdraw or Withhold Life-sustaining Treatments in Critically Ill Children

LSTPedSurvey
Start date: April 2024
Phase:
Study type: Observational

The aim of this study is to investigate attitudes on decisions to withdraw or withhold life-sustaining treatments in critically ill children in Swedish intensive care units. This is a survey among pediatric critical care physicians.

NCT ID: NCT06267911 Not yet recruiting - Critical Illness Clinical Trials

Rehabilitation Gaming System for Intensive Care Units

RGS-ICU
Start date: May 2024
Phase: N/A
Study type: Interventional

Admission to an Intensive Care Unit (ICU) is a potentially traumatic experience for a mentally vulnerable person. Beyond the stress and anxiety associated with the ICU environment and medical procedures, survivors of critical illness are at risk of developing cognitive and psychological sequelae related to Post-Intensive Care Syndrome (PICS). These disorders are associated with high economic, medical and personal costs. This trial aims to evaluate the efficacy of an innovative neuropsychological e-health intervention for early cognitive stimulation and psychological support of people in critical care, i.e. the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) intervention, in improving comfort during ICU admission and cognition and mental health three and 12 months after ICU discharge. The RGS-ICU intervention, applied as an adjunct to standard ICU care, is based on non-immersive virtual reality techniques and has been specifically designed and developed to suit the needs of people in critical care and the characteristics of the ICU environment. To ensure the safety of the intervention, participants' physiological parameters will be automatically recorded by advanced continuous monitoring systems as part of standard ICU care. The investigadors hypothesize that the cognitive stimulation and psychological support protocols of the RGS-ICU intervention, applied as an adjunct to standard ICU care, in addition to being safe for people in critical care units, will improve comfort during ICU admission and cognitive and mental health outcomes after ICU discharge, compared to receiving standard ICU care alone. The findings derived from this trial may contribute to establish a novel and superior paradigm of human-centered ICU care to improve the comfort of people admitted to the ICU. This achievement could also have a relevant impact on medical and economic costs during ICU admission, and on functionality and health-related quality of life after ICU discharge associated with the reduction of cognitive and psychological sequelae linked to PICS. The RGS-ICU intervention has been designed at Corporacion Parc Taulí with the collaboration of the University of the Balearic Islands and has been developed by Eodyne Systems S.L., a company dedicated to the development of science-based technological solutions for intervention, monitoring, diagnosis, and prognosis in stroke and other brain disorders.

NCT ID: NCT06259565 Not yet recruiting - Clinical trials for Non-Invasive Ventilation

Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults

inDEX
Start date: October 2, 2024
Phase: Phase 3
Study type: Interventional

Non-Invasive ventilation (NIV) is a life saving intervention for patients with acute respiratory failure (ARF). Some patients are not able to tolerate the NIV intervention and ultimately fail, requiring the use of invasive mechanical ventilation (IMV) and intubation. Sedation may improve a patient's NIV tolerance. However, this practice has not been adopted by intensivists as the risk of over-sedation resulting in respiratory depression, inability to protect the airway, and inadvertent need for intubation are all large deterrents of sedative use in NIV. The Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Pragmatic Randomized Controlled Trial (inDEX) is looking to evaluate the effectiveness of dexmedetomidine compared to placebo in reducing non-invasive ventilation failures in patients admitted to the hospital with acute respiratory failure.

NCT ID: NCT06256978 Not yet recruiting - Critically Ill Clinical Trials

Continuous Temperature Measurement by Thermal Imaging Camera

TermoCamUCI
Start date: March 2024
Phase:
Study type: Observational

This study explores the significance of body temperature monitoring in hospitalized patients, particularly in critical care environments. With body temperature exhibiting considerable variability, fever, defined at a central temperature of 38.3°C, serves as a pertinent indicator across diverse medical conditions. Temperature measurement methods in Intensive Care Units (ICUs) range from routine peripheral measurements to more invasive central temperature monitoring. Critical patients with fever often receive antibiotic treatment, even without conclusive evidence of infection, as early intervention is linked to improved survival in septic patients. However, the complexity of individual variability, circadian rhythms, medication effects, and methodological limitations underscores the impracticality of defining fever with a singular temperature value. The thermal curve, representing the temporal evolution of temperature, emerges as a nuanced parameter in this context. This study seeks to establish the correlation between axillary temperature measurements, a conventional method, and temperatures recorded by thermal imaging cameras. Widely employed during the Covid-19 pandemic, these cameras offer non-invasive and contactless measurement, mitigating pathogen transmission risks, particularly in patients colonized by multidrug-resistant microorganisms or those with compromised skin integrity. The study also endeavors to evaluate the diagnostic validity of thermal imaging cameras for fever and hypothermia. The integration of thermal imaging cameras into a system capable of automated, real-time peripheral temperature acquisition suggests a potential paradigm shift in ICU temperature monitoring practices. Beyond immediate clinical applications, the amassed data from this system holds promise for training intelligent systems through machine learning algorithms. This strategic integration aims to predict critical events, such as the onset of fever, nosocomial infections, or shock, marking a forward-looking approach to patient management.

NCT ID: NCT06254703 Not yet recruiting - Clinical trials for Acute Kidney Failure Stage 3

Venous Excess and Lung Ultrasound During Continuous Kidney Replacement Therapy in Critically Ill Patients

VExLUS-KRT
Start date: March 1, 2024
Phase:
Study type: Observational

Hemodynamic management of critically ill patients has long been focused on the arterial side of the vasculature by assessing adequate perfusion pressure. However, the venous pressure is also of critical importance. Venous congestion can occur in patients with right ventricular failure, pulmonary hypertension or fluid overload. Fluid overload has harmful effects to end organs causing acute kidney injury (AKI), lung edema, multiorgan dysfunction and death. Vice versa, AKI can aggravate fluid retention and inflammation. The measurement of venous pressure usually relies on central venous pressure (CVP) and inferior vena cava diameter (IVC). However, CVP measurement has been associated with measurement errors and has low accuracy in predicting fluid responsiveness. Moreover, IVC collapsibility or distensibility is a static parameter and is associated with subjective variability. Multiorgan Point-of-Care ultrasound (POCUS) can enhance the management of AKI by enabling the evaluation of renal structural abnormalities and hemodynamic status . POCUS allows the clinician to assess intravascular and pulmonary fluid overload. It has been shown that POCUS is a good parameter to predict global fluid status of the patient . Venous Excess Ultrasound (VEXUS) consists of the evaluation of IVC, hepatic vein, portal vein and intrarenal vein flow pattern. Previous studies showed significant correlation between VExUS score with RRT-free days and guide fluid management in critically ill patients with AKI . VExUS is useful in predicting patients at risk to develop AKI post cardiac surgery . Adding modified lung ultrasound score to the VExUS protocol could help clinician to adjust fluid administration and achieve proper fluid balance during continuous kidney replacement therapy (CKRT). However, the role of using combined VExUS and lung ultrasound in the assessment and guidance of fluid management during CKRT is unknown.

NCT ID: NCT06244381 Not yet recruiting - Critically Ill Clinical Trials

Indirect Calorimetry Versus Urea-creatinine Ratio to Evaluate Catabolism in Critically Ill Patients

Start date: March 1, 2024
Phase:
Study type: Observational

This study aims to evaluate the efficiency of the urea/creatinine ratio as a catabolism marker compared to indirect calorimetry to optimize nutritional support in critically ill patients.

NCT ID: NCT06241417 Not yet recruiting - Acute Kidney Injury Clinical Trials

Ultrasound to Evaluate Acute Kidney Injury

Start date: January 25, 2024
Phase:
Study type: Observational

Acute kidney injury is a common complication in critically ill patients. This condition can significantly prolong the length of hospital stay, increase the cost of hospitalization, and have a high mortality rate and a poor prognosis. Early assessment of patients' prognosis with acute kidney injury is vital for clinical treatment. Point-of-care ultrasound and renal injury biomarkers can be used to evaluate kidney injury at different levels. Therefore, it is speculated that dynamic monitoring can accurately predict the prognosis of patients with kidney injury.