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Delirium 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: NCT06285721 Not yet recruiting - Delirium Clinical Trials

Delirium Treatment With Transcranial Electrical Stimulation

DELTES
Start date: February 26, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with postoperative delirium. To investigate this, will perform a double-blind, randomized, sham-controlled, multicenter trial. To test the safety and feasibility of tACS in delirious patients, the first 30 patients will be randomized to receive either active or sham tACS treatment in a 1:1 ratio through a pilot study. For the main phase of the study, patients will be randomized, resulting in an overall 1:1:1 allocation to standardized tACS, personalized tACS or sham treatment. Electroencephalogram (EEG) will be measured directly before and directly after the first stimulation session to assess whether tACS can reduce relative delta power. tACS or sham treatment will be given once daily for a maximum of 14 days, or until resolution of delirium or discharge (whichever comes first). During the treatment phase, presence and severity of delirium will be assessed daily. After the treatment phase, an additional EEG will be measured. Cognitive status will be assessed three months postoperative.

NCT ID: NCT06279390 Completed - Clinical trials for Intensive Care Unit Delirium

PRE-DELIRIC Prediction Model Plus SMART Care to Reduce the Incidence of Delirium in ICU Patients

Start date: June 8, 2023
Phase:
Study type: Observational

Delirium is a severe acute brain dysfunction characterised by sudden confusion, inattention and fluctuating level of consciousness, which mainly affects intubated intensive care patients. It increases the risk of self-extubation, prolongs ICU stay and increases mortality. The incidence of delirium in ICUs varies, with approximately 33.3% of patients affected, and rates of new-onset and pre-existing delirium range from 4% to 89%. Accurate diagnosis is challenging, with 60-80% of patients remaining undiagnosed. Early detection is critical for intervention and improved outcomes. To address these issues, the PREdiction of DELIRium (PRE-DELIRIC) model incorporates 10 risk factors and predicts delirium within 24 hours of ICU admission, allowing risk stratification into low to very high risk categories. It recalibrates predictive values with a sensitivity of 91.3% and specificity of 64.4% using a cut-off score of 27%. However, its integration into delirium management is underexplored. Delirium risk stratification supports efficient resource allocation, cost control, workload reduction and ethical care, while promptly identifying high-risk patients. In this study, Investigators evaluate the integration of the PRE-DELIRIC model into a comprehensive delirium management approach called PRE-DELIRIC-guided SMART/SmART care. SMART care includes improving familiarity, assessing pain and anxiety, reducing equipment discomfort and cognitive stimulation. Patients with PRE-DELIRIC scores >30% receive SMART care and multidisciplinary involvement, based on the American Delirium Society.

NCT ID: NCT06273358 Completed - Clinical trials for PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUM

Preoperative Sleep Quality and Postoperative Delirium

Start date: August 1, 2023
Phase:
Study type: Observational [Patient Registry]

Background: Delirium is a neurocognitive illness that has lately been connected to sleep difficulties. It is a stressful condition. is still not fully understood. A poor sleep burden and its progress were investigated in this study to determine their correlations with the risk of delirium following surgical procedures. Methods: Between August 1st and December 5th, 2023, 124 patients undergoing non-cardiac general anesthesia (mean age 63.68 ± 8.81 years [SD]; range 46-82 years) reported on their sleep characteristics. PSQI, 1- sleep duration, 2- sleep disturbance, 3- sleep latency, 4- daytime dysfunction resulting from sleepiness, 5- sleep efficiency, 6- overall sleep quality, and 7- usage of sleep medications were among these sleep characteristics. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score ranges from 0 to 21 and is calculated by adding the component scores. Higher scores indicate poorer sleep quality. A three-day median follow-up time was used to analyze hospitalization records to gather data on new-onset delirium (n = 26). Approximately 124 people on average, with a mean.

NCT ID: NCT06268158 Recruiting - Abdominal Surgery Clinical Trials

The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study will be conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit. It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group. During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, will be used.

NCT ID: NCT06268119 Completed - Clinical trials for Delirium, Postoperative

Effectiveness of Delirium Care Protocol After Cardiac Surgery

Start date: March 6, 2023
Phase: N/A
Study type: Interventional

This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery.

NCT ID: NCT06268080 Not yet recruiting - Anesthesia Clinical Trials

Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery

Balanced-2
Start date: March 31, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial (Balanced-2 study) is to compare light to deep general anesthesia using widely available brain monitors, to see if 'light' anesthesia could reduce rates of delirium, cognitive decline, and disability in older adults undergoing major surgery. Delirium is the most common serious surgical complication, occurring in an estimated one in four older adults undergoing major surgery. Delirium causes significant distress to patients and family, and is associated with prolonged hospital stay, physical disability, progression to dementia-like illnesses, and discharge to long-term care. Between 10 - 30% of adults aged 70 years and above have surgery every year, and preserving brain health and wellbeing is an important priority during this time. Older adults (aged ≥65 years, or Indigenous, Pasific patients aged ≥55 years) undergoing major surgery with general anesthesia (excluding heart and brain surgery) and able to provide consent will be able to participate. Participants will be randomized to two groups - a lighter general anesthesia group and a deeper general anesthesia group using processed electroencephalography (a brain monitor that provides information on depth of anesthesia using brain waves). The anesthesiologist will titrate anesthetic drugs according to the brain monitor. Participants will be followed up to determine if they experience delirium after surgery, and longer term impact of delirium such as cognitive and physical decline will also be measured. If found to be effect, this simple, cheap, and widely available treatment could reduce disability, preserve brain health and wellbeing of many older adults undergoing surgery worldwide, and save millions in healthcare dollars.

NCT ID: NCT06256354 Not yet recruiting - Delirium Clinical Trials

Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival

Start date: April 2024
Phase: N/A
Study type: Interventional

Intraoperative hypothermia is common in patients having major surgery and the compliance with intraoperative temperature monitoring and management remains poor. Studies suggest that intraoperative hypothermia is an important risk factor of postoperative delirium, which is associated with worse early and long-term outcomes. Furthermore, perioperative hypothermia increases stress responses and provokes immune suppression, which might promote cancer recurrence and metastasis. In a recent trial, targeted temperature management reduced intraoperative hypothermia and emergence delirium. There was also a trend of reduced postoperative delirium, although not statistically significant. This trial is designed to test the hypothesis that intraoperative targeted temperature management may reduce postoperative delirium and improves progression-free survival in older patients recovering from major cancer surgery.

NCT ID: NCT06255132 Recruiting - Clinical trials for Postoperative Delirium

Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium

Start date: March 9, 2023
Phase: N/A
Study type: Interventional

The rate of postoperative delirium in patients who underwent cardiac surgery is very high. Different predictors and/or scores were studied for the prediction of Post Operative Delirium (POD)after heart surgery, but none of them was validated. The investigators aim to explore the role of pupillary alterations during anesthesia in open-heart surgery. The goal of this prospective study is to evaluate if pupil alterations during cardiac surgery, evaluated by an automated pupillometer (NPi-200) ( AP), could predict postoperative delirium.

NCT ID: NCT06248684 Not yet recruiting - Clinical trials for Postoperative Delirium

Prevention of Postoperative Delirium in Elderly Patients

PODproject
Start date: February 6, 2024
Phase: N/A
Study type: Interventional

Prevention of Postoperative Delirium in the care of Elderly Patients. A Monocentric, Prospective Intervention Study With the Question of Whether the Incidence, Length and Severity of Postoperative Delirium Can be Reduced by Implementing a Standardised, Multidimensional Delirium Management Protocol.