Clinical Research Directory

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.

Pilot Study of a Multidisciplinary Intervention in ICU Survivors at Risk for Psychological or Physical Morbidity

Pilot study of the feasibility and utility of an early, in-hospital multidisciplinary intervention in ICU survivors at risk for psychological and physical problems post-ICU stay

Improving Outcomes in PICS With Home-Based Program of Rehabilitation and Health Coaching

The purpose of this study is to gather information on the effectiveness of a home-based rehabilitation program that also includes health coaching in patients who may suffer from post-intensive care syndrome (PICS). Many patients who are admitted to a hospital ICU suffer from new or worsening symptoms related to their medical condition and ICU care. These new or worsening symptoms may persist for some time and are collectively called post-intensive care syndrome (PICS).

Post-ICU Syndrome Over Time in Patients With Respiratory Failure

Intensive Care Units (ICU) stabilize and maintain vital functions in critically ill patients, optimizing their survival. However, patients with prolonged stays may develop Post-ICU syndrome , characterized by physical, cognitive and psychological dysfunctions. This syndrome considerably affects the quality of life of patients. The risk of post-ICU syndrome is associated with factors such as advanced age, delirium, prolonged sedation and mechanical ventilation. The main objective of this study is to assess the temporal evolution of post-ICU syndrome in patients who required mechanical ventilation for more than 48 hours, analyzing its incidence, associated risk factors and the impact on their long-term quality of life. This cross-sectional study evaluates the presence of post-ICU syndrome in 2025 in patients who have been admitted to the ICU during 2021 and 2024 who required invasive mechanical ventilation for more than 48 hours. Of this total, deceased persons, those who did not give their consent, and minors will not be included.

Application of Large Language Models Techniques to Post-ICU Syndrome Management in Critically Ill Patients: A Fully Longitudinal Mixed Study

The goal of this clinical trial is to evaluate whether Large Language Models (LLMs) combined with an optimized care program can effectively manage Post-Intensive Care Syndrome (PICS) in adult ICU survivors (aged ≥18 years) discharged from a tertiary hospital in China. The main questions it aims to answer are: * Does the intervention (optimized program + LLMs) improve physical, psychological, cognitive, and social function recovery compared to standard care or the optimized program alone? * How do patients experience and perceive the utility of LLMs in PICS self-management during recovery? Researchers will compare three groups: 1. Group A (routine care) 2. Group B (optimized program without LLMs) 3. Group C (optimized program + LLMs) to see if adding LLMs significantly enhances PICS symptom management, patient self-efficacy, and quality of life over 6 months post-discharge. Participants will: * Install and use the Kimi Smart Assistant LLM (Group C only) for health queries under nurse supervision. * Complete standardized questionnaires at discharge (baseline), 7 days, 1 month, 3 months, and 6 months post-discharge: * PICS Symptom Questionnaire (PICSQ) * Pittsburgh Sleep Quality Index (PSQI) * Anxiety (GAD-7) and Depression (PHQ-9) scales * Self-Management Ability Scale (AHSMSRS) * Attend semi-structured interviews (Group C only) at 3 and 6 months to share experiences with LLM use.

A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol

This pooled analysis will assess Cognitive, Mental Health, Functioning, and Quality of Life Assessments data from the Phase 3 registration studies INSPiRE-ICU 1 (NCT05312385) and INSPiRE-ICU 2 (NCT05327296) to explore potential differences in Long-Term Outcomes at 3 and 6 months after treatment between critically ill mechanically ventilated patients sedated with inhaled isoflurane compared to sedated with intravenous propofol. The analyses were pre-planned and agreed prior to completion of enrollment of either study.

Hand and Arm Rehabilitation Using VR

Patients admitted to the ICU due to critical illness often experience physical, mental, cognitive, or social issues. Research indicates that inadequate physical recovery is associated with lower handgrip strength, and hand function in ICU patients is lower compared to healthy individuals. To address this, a Virtual Reality (VR) exergame was developed to aid rehabilitation. This study aims to investigate the effect of a 4-week VR-exergame intervention on handgrip strength, hand and arm functionality, balance, mobility, and support needs in ICU patients staying for 48 hours or longer. It is a multicenter mixed-methods randomized controlled trial involving adult ICU patients. The intervention involves a 4-week VR-exergame program. Main study parameters include handgrip strength, hand and arm functionality, range of motion, balance, mobility, and support needs. The burden and risks associated with participation are minimal, as VR-based exercises are deemed safe and voluntary. Overall, the study aims to assess the effect of incorporating VR-based rehabilitation into standard care for ICU patients.