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Delirium clinical trials

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NCT ID: NCT04270331 Completed - Pain Clinical Trials

Assessment and Management of Pain, Agitation, Delirium and Sleep Deprivation (PADS) in ICU by PADS Protocol, Thailand

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

The investigators proposed that pain, agitation, delirium and sleep deprivation protocol (PADS) will help improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.

NCT ID: NCT04263844 Completed - Emergence Delirium Clinical Trials

Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

Start date: January 10, 2019
Phase: Phase 4
Study type: Interventional

This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. There were 64 children obtained by consecutive sampling, who underwent eye surgery in investigator institution during February-May 2019. The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events. Data analysis using Chi Square test and Mann-Whitney test.

NCT ID: NCT04250610 Recruiting - Clinical trials for Postoperative Delirium

Survey Assessing the Level of Knowledge of Postoperative Delirium in Poland.

PODinPOL
Start date: February 27, 2020
Phase:
Study type: Observational

Postoperative Delirium (POD) is one of the most common complications occurring after surgery with an incidence ranging from 4 to 53%. It may lead to increased postoperative morbidity and mortality, with loss of independence and cognitive dysfunction in certain groups of patients. Aiming to reduce the incidence of POD and improve the outcome of patients diagnosed with POD, it is necessary to raise awareness regarding POD. The most important issue are: identification of risk factors, improved monitoring, necessary prevention and adequate treatment. The Polish Society of Anaesthesiology and Intensive Therapy (PTAiIT) has made an attempt to improve the situation in Poland by testing the implementation of official POD guidelines published by the European Society of Anesthesiology in year 2017. While the guidelines provide recommendations for daily practice it is necessary to identify the degree of their implementation in each country. Therefore survey has been prepared regarding postoperative delirium in Poland. This Survey has been submitted to the Bioethical Committee of the Pomeranian Medical University in Szczecin (Poland) and received a waiver due to the non-interventional, observational character of the study (decision no. KB-0012/06/01/2020/Z).

NCT ID: NCT04249141 Withdrawn - Pain Clinical Trials

Determinants of Implementation Success Coordinating Ventilator, Early Ambulation and Rehabilitation Efforts

DISCOVER-ICU
Start date: January 28, 2020
Phase:
Study type: Observational

There is a fundamental gap between the discovery of proven-effective intensive care unit (ICU) sedation, mechanical ventilation, mobility, and symptom management strategies and approaches that can equip ICU providers with the skills necessary to reliably adopt these interventions in everyday practice. Until this gap is filled, the millions of patients with heart, lung, and blood disorders admitted to ICUs annually will remain at risk for avoidable physical, mental, and cognitive health impairments that may persist for months to years after hospital discharge. In the proposed study, the investigative team will continue their partnership with the Society of Critical Care Medicine's (SCCM's) ICU Liberation Collaborative. Guided by the Consolidated Framework for Implementation Research, the overall objective of the Determinants of Implementation Success Coordinating Ventilator, Early Ambulation and Rehabilitation Efforts in the ICU (DISCOVER-ICU) study is to develop multilevel implementation strategies to enhance sustainable adoption of the ABCDEF (Assess, prevent, and manage pain and delirium, both spontaneous awakening and breathing trials, choice of sedation, early mobility, family engagement) bundle in routine ICU practice. Using a multiphase, sequential, mixed-methods design, this study has three specific aims: 1) estimate the effects of patient-level characteristics on ABCDEF bundle adoption; 2) examine unit-level variation in ABCDEF bundle adoption and associated provider- and organization-level characteristics; and 3) determine which implementation strategies result in the greatest adoption of the ABCDEF bundle. Existing deidentified data will be obtained from >15,000 patients, >5,000 interprofessional ICU team members, and 68 hospitals participating in the ICU Liberation Collaborative to achieve specific aims 1 and 2. For specific aim 3, data collection will be extended using interprofessional ICU team surveys, a modified Delphi process, and concept mapping to achieve greater understanding of implementation strategies that prove most effective for ABCDEF bundle adoption. Results of this work will directly lead to the development of implementation strategies that are adaptable, responsive to community needs, and account for the cultural and organizational factors necessary to increase ABCDEF bundle adoption. These implementation strategies will then be tested in a future cluster randomized hybrid II implementation effectiveness trial.

NCT ID: NCT04247646 Active, not recruiting - Pain, Postoperative Clinical Trials

SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty

SLOPE
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Prescription opioid misuse and its associated negative effects have become an epidemic in the United States, and post-operative opioid use contributes to this terrible problem. Alternative strategies to opioid prescribing are thus highly sought after in the post-operative setting. Importantly, sleep and pain have a bi-directional relationship, and inadequate or impaired sleep regularly occur following orthopedic operations. Melatonin is an endogenous sleep hormone that can be administered exogenously, and that has been shown to have some potential as an analgesic agent. Here, using the premise that melatonin may improve sleep and pain in the post-operative setting, the investigators propose a randomized clinical trial in 120 participants undergoing total knee arthroplasties. Patients will be randomized to receive either sublingual melatonin 5 mg or matched placebo starting on post-operative day (POD) 0 and through POD . The investigators will measure post-operative opioid usage as the primary outcome, and post-operative pain scores as a secondary outcome. The primary safety outcome will be sedation level, as measured by the Richmond Agitation Sedation Scale (RASS). Sleep will be measured objectively using wrist-worn actigraphy. Participants will be followed through POD 28, and will also have baseline data on sleep, pain, and cognition obtained prior to surgery.

NCT ID: NCT04246892 Terminated - Delirium Clinical Trials

Impact of Alarm Reduction on Delirium in ICU

ALADIN
Start date: February 3, 2020
Phase:
Study type: Observational [Patient Registry]

Delirium is an acute and fluctuating disturbance of consciousness and can occur in 80% of critically ill patients. Delirium is more frequent in mecanically ventilated patients and is associated with longer hospital stay, increased cognitive impairment and mortality. On the occasion of the change of the monitors in the ICU ward, allowing a total withdrawal of alarms in patients room, this study evaluates the prevalence of delirium before and after the alarm withdrawal. During the first period the patients will be monitored as usual, and during the second period patients will be monitored without alarms ringing in patients room. Delirium will be screened with a validated, clinical tool.

NCT ID: NCT04227873 Not yet recruiting - Delirium Clinical Trials

Sleep and Cognition After Ambulatory Hip and Knee Arthroplasty

Start date: March 2020
Phase:
Study type: Observational

Sleep and rest are key elements in postoperative rehabilitation and recovery. There are complex relations between major surgery, sleep disturbance and complications. Major surgery leeds to severe postoperative sleep disturbances, initially reducing REM sleep time and disturbing the remaining sleep stages. Major surgery is again a risk factor for postoperative delirium and other cognitive impairment. The underlying mechanisms includes pain, opioid medication, sleep disturbances and neuroinflammation, along with external factors as noise during hospitalisation. The physiologic stress from sleep disturbances and sleep deprivation is associated with blood-brain barrier impairment, inflammation, decreased restitution, altered nociceptive function. Likewise, undiagnosed and untreated sleep apnea is a risk for postoperative complications and is itself affected by anesthesia and some analgesics (i.a. opioids). Fast-track surgery development has led to restitution period shortening, optimized pain management reducing opioid use, postoperative inflammatory stress response reduction and less delirium. Evolution of hip and knee arthroplasty(THA/TKA), organisation, optimized pain management and pharmacologic modification of inflammatory response by high dose steroid has permitted to perform these surgeries in an outpatient setting. Previous studies of fast-track THA/TKA using multimodal opioid-sparring analgesia, however neither using high dose steroids nor in an out patient setting, have demonstrated REM sleep period reduction from a normal range of 18% preoperatively to 1% postoperatively. However, changes in sleep architecture after THA/TKA in at setting attempting to minimise abnormal sleep by means of ambulatory surgery added to perioperative reduction of inflammatory response to surgery, pain and opioid use by high dose steroid, haven't been studied. The purpose of this study is to investigate how much an optimized ambulatory THA/TKA , reducing pain and inflammatory response to surgery and opioid use by high doses steroid can conserve the preoperative sleep architecture.

NCT ID: NCT04219735 Completed - Delirium Clinical Trials

Effect of Minocycline on Delirium Incidence in Critically Ill Patients

Start date: January 30, 2020
Phase: Phase 2
Study type: Interventional

Delirium is a disorder of consciousness characterized by an acute onset and fluctuating course of impaired cognitive functioning. It is associated with unfavorable outcomes in hospitalized patients, including longer hospital length of stay, need for subsequent institutionalization and higher mortality rates. Patients in the intensive care unit (ICU) under mechanical ventilation and older age are at higher risk for the development of delirium. Several studies suggest that minocycline, through its anti-inflammatory effect, was able to prevent neuronal dysfunction in different models of ICU-related diseases. Thus, the present study aimed to evaluate the effect of minocycline on delirium development in critically ill patients. Patients will be randomized into one of two groups: the intervention group that will receive 100mg of minocycline 2 times a day and the placebo group. Medication or placebo will be continued for 28 days or until ICU discharge (whichever occurs first). Delirium will be diagnosed by the CAM-ICU. Coma will be defined by the Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 and biomarkers will be used as alternative outcomes related to the pathophysiology of the disease (IL-1, IL-6, IL-10, and BDNF).

NCT ID: NCT04218461 Completed - Delirium Clinical Trials

PREdiction of DELIRium in Medical ICU Patients

Start date: November 5, 2019
Phase:
Study type: Observational

In intensive care unit (ICU) patients, the ability to predict delirium may help reduce its incidence, duration, and severity. The PREdiction of DELIRium in ICU (PRE-DELIRIC) model was recently developed for this purpose. Our aim was to test the PRE-DELIRIC model in the medical ICU.

NCT ID: NCT04217915 Recruiting - Analgesia Clinical Trials

A Survey of Management of Analgesia, Sedation and Delirium in ICU Patients in China

SASE
Start date: July 12, 2021
Phase:
Study type: Observational

In 2018, the severe medicine branch of the Chinese Medical Association and the American Society of severe medicine successively updated the pain and sedation guidelines for severe patients (PADIS guidelines). In addition to the update of the original evaluation and management of pain and sedation and delirium, the new guidelines also increased the monitoring and management of early activities and sleep quality for severe patients. Therefore, it is necessary for us to investigate the compliance of the new guidelines for analgesia, sedation and delirium management among the medical staff of critical care, so as to find out the existing problems in the management of analgesia, sedation and delirium in critical care patients, and find solutions to improve the overall quality level of our management of critical care patients