Delirium Confusional State

12

Review clinical trials related to Delirium Confusional State. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

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Status: Not yet recruiting

Patients With Long-stay at ICU: Factors and Evaluation - Feasibility Study

Every year, many critically ill patients are admitted to an intensive care unit (ICU). Most stay only a few days, but a smaller group stays much longer. In Sweden, patients treated in the ICU for more than 10 days account for about 35 percent of all ICU days. Little is known about why some patients need prolonged intensive care, or how their lives are affected afterwards. LIFE-ICU is a planned national observational cohort study of adult patients in general intensive care. This record covers the feasibility study that precedes the main study, including its pilot part. The feasibility study does not change the care patients receive. About 200 adult patients who have been treated in a general ICU for more than four days will be included consecutively at the participating ICUs. For each patient, a designated next of kin, usually the family member or friend most involved during the ICU stay, is invited to take part. Information is collected from the medical record about health before admission and about the ICU stay, for example organ support, delirium, nutrition and mobilisation. At ICU discharge, patients answer four questions about distressing memories from the ICU. Six months after final discharge from intensive care, patients are contacted by letter and then by telephone. They answer questions about health status, quality of life, anxiety and depression, post-traumatic stress, fatigue, life satisfaction, frailty, overall function and occupational status. Designated next of kin answer questions about their own life satisfaction, post-traumatic stress and caregiver burden, provided that the patient is alive at the time of follow-up. A selection of patients and next of kin are also invited to an interview about their experiences of intensive care and of recovery. Staff who collect the data answer an anonymous questionnaire about how the data collection worked. The study compares patients whose total ICU stay is more than 10 days with patients whose stay is more than 4 days and at most 10 days. The main purpose of the feasibility study is to find out whether the planned data collection works in practice. This is assessed against criteria set in advance: how many of the eligible patients can actually be included, how complete the collected data are, and how many patients and next of kin respond at six months. The pilot part also provides the estimates needed to plan the main study, such as the proportion of patients who stay in the ICU for more than 10 days and how the measured factors are distributed. Hypothesis: the feasibility study tests the hypothesis that the planned data collection is feasible within routine intensive care and yields data of sufficient completeness and quality to inform the design of the main study. The main study is designed to test the hypothesis that factors present before ICU admission and during the first days of intensive care contribute to a prolonged ICU stay, that some of these factors can be modified, and that they are also associated with worse long-term outcome. The feasibility study is not powered to test this hypothesis. The long-term goal is better knowledge about prolonged intensive care, so that prognostic information can become more accurate, care can be planned more individually, and patients and next of kin can receive better support during and after the ICU stay.

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Uppsala UniversityUpdated: Oct 1, 2026Locations: 4
Eligibility criteria

ICU stay of more than 4 days (96 hours) in a participating general intensive car... [+6]

6 days (144 hours) or more since ICU admission at the time of inclusion [+6]

Status: Recruiting

Triple Sleep-promotion Protocol for Delirium Prevention in Intensive Care Patients

Delirium is a common complication in intensive care units (ICUs) and may be associated with sleep disruption and frequent nighttime disturbances. This randomized controlled trial will evaluate whether a multicomponent nighttime sleep-promotion intervention, called the Triple Sleep-Promotion Protocol, can reduce the occurrence of new-onset delirium in adult ICU patients. The study is being conducted in four ICUs in Türkiye. Eligible patients who do not have delirium at the beginning of the study will be randomly assigned to either the intervention group or the control group. The intervention includes clustering nighttime nursing care, offering an eye mask and earplugs during protected sleep periods, and reducing avoidable nighttime light and noise whenever clinically feasible. Patients in the control group will receive usual ICU care. Patient safety and clinically necessary care will take priority over all sleep-promotion procedures. Participants will be followed during their ICU stay for up to five days. Delirium will be assessed twice daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Nighttime sleep quality will also be assessed each morning using the Richards-Campbell Sleep Questionnaire. The primary aim is to determine whether the Triple Sleep-Promotion Protocol reduces the incidence of new-onset delirium compared with usual ICU care.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Naile ALANKAYAUpdated: Sep 9, 2026Locations: 1
Eligibility criteria

Age 18 years or older. [+6]

Positive CAM-ICU assessment at baseline. [+5]

Status: Not yet recruiting

Exploring the Effectiveness of Intelligent Audiovisual Interventions in Delirium, Agitation, and Pain Among Middle Aged and Elderly Patients in Emergency Intensive Care Units: A Quasi-Experimental Study

The goal of this nonrandomized, quasi-experimental clinical trial is to evaluate whether an intelligent audiovisual intervention can prevent delirium and reduce delirium severity, agitation, and pain among adults aged 55 years or older admitted to an emergency intensive care unit (EICU). The main questions it aims to answer are: Does the intelligent audiovisual intervention reduce the incidence and severity of delirium compared with routine care? Does the intervention improve agitation and pain scores compared with routine care? Researchers will compare participants receiving the intelligent audiovisual intervention plus routine care with participants receiving routine care alone. Participants will be assigned according to the week of EICU admission: those admitted during odd-numbered weeks will receive the intervention, while those admitted during even-numbered weeks will receive routine care. Participants in the intervention group will: View a structured audiovisual program containing a prerecorded message from a family member, current date and weather information, and images of the area surrounding the hospital. Receive the intervention for 2 minutes per session, 3 times daily for 2 consecutive days, beginning within 24 hours after EICU admission. Participants in both groups will undergo assessments of delirium, agitation, and pain 3 times daily for 2 consecutive days. Delirium incidence and severity will be assessed using the Confusion Assessment Method for the Intensive Care Unit-7 (CAM-ICU-7). Agitation will be evaluated using the Richmond Agitation-Sedation Scale (RASS), and pain will be assessed using either the Numerical Rating Scale (NRS) or the Face, Legs, Activity, Cry, and Consolability (FLACC) scale.

Participants needed: 128
Trial details
Age: 55+Biological sex: AllType: InterventionalSponsor: Taipei Veterans General Hospital, TaiwanUpdated: Aug 20, 2026
Eligibility criteria

Aged 55 years or older. [+5]

Diagnosed visual or hearing impairment that would interfere with receiving the a... [+7]

Status: Recruiting

ICU Delirium Playbook Training Study for ICU Nurses

Delirium is a common and serious acute neurocognitive disorder among critically ill patients, affecting up to 50% of intensive care unit (ICU) patients and up to 80-90% of those receiving invasive mechanical ventilation. It is associated with increased mortality, prolonged ICU and hospital length of stay, long-term cognitive impairment, higher healthcare costs, and reduced quality of life for patients and their families. Despite the availability of validated screening tools such as the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), delirium remains underrecognized and undertreated in routine clinical practice, largely because of inadequate healthcare professional education and inconsistent implementation of evidence-based recommendations. Nurses play a central role in the prevention, early detection, and management of delirium, making targeted educational interventions essential to improve clinical practice. The ICU Delirium Playbook is a multimedia educational program developed by the University of California, San Diego, consisting of brief instructional videos and realistic clinical scenarios designed to improve nurses' knowledge and confidence in delirium assessment and management. The aim of this quasi-experimental pre-post study is to evaluate the effectiveness of the ICU Delirium Playbook among intensive care nurses at Pisa University Hospital. The primary objective is to determine whether participation in the educational program improves nurses' knowledge of delirium. Secondary objectives are to evaluate participants' satisfaction with the training, assess changes in clinical attitudes and behaviors related to delirium care, validate the Italian version of the behavioral assessment questionnaire, and explore the impact of the educational intervention on patient outcomes, including the frequency of delirium recognition and the duration of delirium episodes. The study will be conducted in a single center using a pre-intervention and post-intervention design. Before the educational intervention, participating nurses will complete questionnaires evaluating delirium knowledge, attitudes, and clinical behaviors. During the same period, retrospective and prospective clinical data will be collected from medical records of adult patients admitted to the Cardio-Thoracic-Vascular Intensive Care Unit, including delirium assessment and diagnosis. Following baseline data collection, nurses will attend the ICU Delirium Playbook educational session, lasting approximately four hours. After completion of the videos, nurses will repeat the same questionnaires, and patient clinical data will be collected again during a six-month post-intervention period. The study is based on Kirkpatrick's Four-Level Model for training evaluation, assessing participants' reaction to the educational intervention, learning outcomes, behavioral changes in clinical practice, and the effects on patient care. It is expected that the intervention will improve nurses' knowledge and evidence-based management of delirium, increase the recognition of delirium in ICU patients. The findings of this study will provide evidence regarding the effectiveness of the ICU Delirium Playbook in the Italian critical care setting and may support the implementation of standardized delirium education programs in intensive care units.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Nicola PagnucciUpdated: Aug 12, 2026Locations: 1
Eligibility criteria

nurses working in the ICU of the Pisa University Hospital (AOUP). [+1]

Status: Not yet recruiting

Effects of Different Types of Music Therapy Combined With Mindful Breathing on Delirium, Pain, and Anxiety in ICU Patients

Delirium is the most common and severe neuropsychiatric complication in the Intensive Care Unit (ICU), with an incidence as high as 87% in the United States, 75.6% in medical ICUs in Taiwan, and 41.7% in surgical ICUs, with patients developing delirium an average of 2.6 days after admission. Delirium is associated with prolonged mechanical ventilation, increased complications, higher in-hospital mortality, greater psychological burden on family members, and elevated clinical pressure on healthcare staff. The National Institute for Health and Care Excellence (NICE) guidelines recommend prioritizing non-pharmacological interventions for delirium prevention, among which music intervention has emerged as one of the most promising strategies due to its low risk, low cost, and feasibility in the ICU setting. Although several international studies have supported its potential benefits, evidence remains inconclusive. Mindfulness-based approaches represent another non-pharmacological strategy that intentionally directs attention to present-moment bodily sensations; mindful breathing exercises are particularly suitable for ICU patients, as they only require patients to adopt a comfortable position in bed and focus on each inhalation and exhalation under guidance, quickly restoring awareness to present bodily experience. Incorporating mindful breathing before and after music listening may therefore facilitate emotional regulation and present-moment awareness, enhancing patient engagement and attentional focus during the intervention. Existing delirium prevention studies in Taiwan have predominantly employed multicomponent care bundles, leaving a gap in empirical evidence regarding music as a standalone intervention. Moreover, scholars have highlighted that musical preference and cultural background influence patients' psychological responses to music, underscoring the importance of cultural appropriateness. In response to this gap, the present study proposes a music intervention combining classical music and Taiwan-localized music with mindful breathing exercises, aiming to examine the effects on ICU delirium incidence and severity, compare the effectiveness of classical versus Taiwan-localized music, and explore the potential benefits on patient anxiety and pain, with the hope of providing a culturally informed, evidence-based music repertoire to guide clinical practice in Taiwan.

Participants needed: 51
Trial details
Age: 20+Biological sex: AllType: InterventionalSponsor: Chimei Medical CenterUpdated: Jun 3, 2026
Eligibility criteria

Adults aged 20 years or older who can communicate verbally or in writing [+3]

Positive delirium screening at ICU admission [+2]

Status: Not yet recruiting

Phenobarbital for Agitated Delirium

The goal of this clinical trial is to test whether the medication phenobarbital is as effective for treating agitated delirium among adult patients admitted to the intensive care unit. Agitated delirium is a condition involving confusion and impulsiveness which is dangerous to both patients and healthcare providers. The main questions this trial aims to answer include: * Can phenobarbital decrease the amount of time patients with agitated delirium spend in the intensive care unit and the hospital? * Does phenobarbital decrease the amount of additional calming medications patients with agitated delirium need? Researchers in this study will compare phenobarbital to other medications commonly used to treat agitated delirium. Participants will be monitored closely to make sure they remain safe and to measure how well their agitation and confusion are managed while they are in the ICU.

Participants needed: 150
Trial details
Phase: Phase 3Age: 21+Biological sex: AllType: InterventionalSponsor: Duke UniversityUpdated: Apr 23, 2026Locations: 1
Eligibility criteria

Adult Patients identified by providers to have agitated or hyperactive delirium

Pregnancy [+3]

Status: Recruiting

Using Virtual Reality to Improve Medical Training

As the U.S. population ages, future physicians must be prepared to care for older adults with multiple health conditions and complex needs. This study will test whether cinematic virtual reality (VR)-an immersive, interactive learning tool-is more effective than traditional lectures in helping medical students learn about geriatric care. Students who complete the VR training will experience realistic patient scenarios that show what can go wrong in medical care and learn how to apply osteopathic principles to improve outcomes. Researchers will compare students' performance on a clinical skills assessment and explore their experiences with the VR training. The goal is to determine whether cinematic virtual reality can better prepare students for residency and improve their ability to provide compassionate, high-quality care for older adults.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ohio UniversityUpdated: Apr 21, 2026Locations: 1
Eligibility criteria

Not listed

Status: Not yet recruiting

Lorazepam for Delirium Prevention in Critically Ill Patients With High Anttila-Index

Delirium is a neuropsychiatric syndrome characterized by cognitive and attentional deficits, circadian rhythm, emotional and psychomotor dysregulation. It is frequently encountered in patients admitted to an Intensive Care Unit (ICU) with a prevalence of 20-80% and associated with higher morbidity and mortality, prolonged hospitalization and cognitive impairment after hospitalization. Alcoholism is an important risk factor that favors the development of delirium and a common comorbidity in patients admitted to the ICU. Patients with alcohol use disorders can develop a withdrawal syndrome after cessation of alcohol consumption. The most severe form of alcohol withdrawal is the alcohol withdrawal delirium, which is characterized by a profound state of confusion. Early recognition and treatment significantly diminish severe complications of alcohol withdrawal delirium, including mortality. The common pharmacological prevention and therapy of alcohol withdrawal syndrome is the administration of benzodiazepines, which have the potential to prevent or mitigate alcohol withdrawal delirium. In the ICU setting the diagnosis of alcoholism based on self-report can be unreliable and complicated by acute illness. The Anttila-Index is a parameter calculated from the carbohydrate-deficient transferrin and the gamma-glutamyltransferase. It has a high sensitivity and specificity for excessive alcohol consumption. Therefore, the Anttila-Index of patients admitted to the ICU could help identify patients at risk for developing delirium due to alcoholism or due to alcoholism in combination with other risk factors. Schreiber et al. recently (October 2023) found significantly higher Anttila-Index in patients with delirium on a medical ICU. The investigators postulate that this also applies to the patients admitted to the mixed (medical and surgical) ICU at the University Hospital Basel (USB), since surgery is an additional crucial risk factor for delirium development. Hypothesis: ICU delirium can be reduced by careful preventive administration of lorazepam in patients admitted to the ICU with an Anttila-Index at or above the cutoff value of four.

Participants needed: 260
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, Basel, SwitzerlandUpdated: Feb 27, 2026
Eligibility criteria

Emergency/unplanned admission to the ICU [+4]

Pre-existing delirium [+6]

Status: Not yet recruiting

Delirium and Heart Failure

Biomarkers such as Systemic Immune-Inflammation Index (SII) and TG/Glucose Ratio (TyG) have shown promise in predicting delirium, reflecting the roles of inflammation and metabolic disturbances in its pathophysiology. This study aims to compare the predictive value of SII and the TyG ratio among other chemical and physiological biomarkers for diagnosing delirium and detecting its severity in older adults with heart failure. These biomarkers reflect different pathophysiological pathways implicated in delirium, including inflammation, cardiovascular stress, and metabolic dysfunction. By evaluating their individual and combined predictive abilities, this research seeks to identify potential tools for early identification of patients at high risk for delirium

Participants needed: 100
Trial details
Age: 60+Biological sex: AllType: ObservationalSponsor: Ain Shams UniversityUpdated: Dec 24, 2025Locations: 1
Eligibility criteria

cognitive impairment [+5]

Status: Not yet recruiting

Point-of-Care AI Assistance and Critical Care Outcomes: A Randomized Trial

This is a prospective, unmasked, randomized, multicenter clinical trial evaluating the impact of point-of-care large language model (LLM)-based decision support on diagnostic accuracy and clinical outcomes in adult medical intensive care unit (MICU) patients. Consecutive adult ICU admissions at participating community hospitals (initially MetroWest Medical Center and St. Vincent Hospital) will be screened for eligibility. Eligible patients will be randomized 1:1 to standard care or an AI-assisted group. In both arms, initial evaluation and management will follow usual practice. For patients randomized to AI assistance, de-identified admission data (history and physical, labs, imaging reports, and other relevant documentation) will be formatted and submitted to a state-of-the-art LLM (ChatGPT-5) at the time of admission. The AI-generated differential diagnosis and therapeutic recommendations will be provided to the admitting team for consideration. For the standard care arm, LLM output will be generated but not shared with clinicians. After discharge, a masked chart review will determine the "ground truth" primary diagnosis and extract outcomes including: Primary Outcome - a composite of medical errors (from time of ICU admission through day 7 of ICU stay, or ICU discharge, whichever comes first); Secondary Outcomes - 90-day mortality, ICU and hospital length of stay, and ventilator-free days.

Participants needed: 1,000
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: MetroWest Artificial Intelligence Research WorkgroupUpdated: Dec 18, 2025Locations: 1
Eligibility criteria

Adult patients (≥ 18 years) admitted to the medical intensive care unit (MICU) a... [+2]

Transfers to the MICU from outside hospitals, operating room, or post-anesthesia... [+5]

Status: Recruiting

Clinical Trial Protocol: Alzheimer's Dementia Underlying Encephalopathy

The goal of this clinical trial is to determine if utilizing the Quest AD-Detect blood test, while patient's are hospitalized for a cognitive diagnosis (such as delirium or encephalopathy), will result in an earlier diagnosis of underlying Alzheimer's disease. * Will this blood test have the ability to distinguish between Alzheimer's disease and other causes of cognitive impairment in the inpatient setting? * Neurology Clinic will complete a 6-month post-hospitalization follow up with patients who have had the Quest AD-Detect Alzheimer's Disease blood test completed while they were inpatient to discuss the risk assessment portfolio

Participants needed: 30
Trial details
Age: 60-90Biological sex: AllType: InterventionalSponsor: Covenant Health, USUpdated: Oct 29, 2025Locations: 6
Eligibility criteria

Ages 60 to 90 years old [+2]

Age under 60 years [+1]

Status: Not yet recruiting

Management of Non-pharmacologic Delirium With the Use of a Nursing-led E-health Project: a Randonmized Controlled Trial

Application of an action protocol focused on the application of non-pharmacological interventions for managing delirium in the process of prevention, diagnosis and treatment, evaluated using an e-health intervention, with a tablet to introduce on it the data about the prevention, diagnostic and treatment process of each recluted patient, in the Igualada Hospital Center, once a day.

Participants needed: 65
Trial details
Age: 80-130Biological sex: AllType: InterventionalSponsor: Universitat de LleidaUpdated: May 29, 2025Locations: 1
Eligibility criteria

Age over 80 years [+3]

Age under 80 years [+1]