Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294158
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-27
Brief Title:
Light and Noise Objectively Assessing Environmental Risk Factors for Delirium in the ICU
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Light and Noise Objectively Assessing Environmental Risk Factors for Delirium in the ICU
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LANYARD-ICU
Brief Summary:
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 ie risk factors
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 ie risk factors
Detailed Description:
Delirium - derived from the word lira Latin for furrow - literally means to get off track Historically signs and symptoms of delirium have been taunted as insanity Recognition of delirium as a medical entity with relevance to both morbidity and mortality especially in in critically ill patients is a relatively recent development However research into delirium its prevention and treatment is now in focus of scientific efforts by epidemiologic researchers and international societies alike
Delirium now is a medical condition both recognised in current versions of the International Classification of Diseases ICD-10 and the Diagnostic and Statistical Manual of Mental Disorders DSM-5 It is characterised by some disturbance in attention and awareness acute onset and at least one additional disturbance in memory orientation language visuospatial ability or perception which cannot better be explained by another neurocognitive disorder and when there is evidence that the disturbances are a 34direct physiological consequence34 of another medical condition substance intoxication or withdrawal toxin or various combinations of causes
While historically sometimes regarded as an inalterable consequence of disease delirium has been recognised as a significant contributor to both morbidity and even mortality in hospitalised patients especially in critically ill individuals who require intensive care Several risk factors for the development of delirium in intensive care units have been identified previously However many of these are factors not modifiable by caregivers eg advanced age frailty pre-existing cognitive impairment smoking alcohol consumption previous isolation etc While some aspects of environment and interventions especially endotracheal intubation use of physical restraints and sedation with benzodiazepines postoperative pain have been found to be strongly associated with the development of delirium assessment of the ICU environment itself as a potential modifiable risk factor is insufficient to this date
Intensive care is known to be associated with high noise levels attempts to reduce this noise pollution or provide protection from it may be worthwhile interventions to reduce delirium incidence However despite first attempts to establish associations between noise levels and delirium occurrence no target values for possible future interventions have been established yet
This study seeks to evaluate whether potentially modifiable environmental factors in intensive care units such as disturbances by noise or dazzling by light are associated with the development of delirium in critically ill patients 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 Such changes could potentially improve outcomes which would be much desired progress in delirium care where both non-pharmacologic and pharmacologic therapeutic approaches have not convincingly been shown to be of benefit
Delirium now is a medical condition both recognised in current versions of the International Classification of Diseases ICD-10 and the Diagnostic and Statistical Manual of Mental Disorders DSM-5 It is characterised by some disturbance in attention and awareness acute onset and at least one additional disturbance in memory orientation language visuospatial ability or perception which cannot better be explained by another neurocognitive disorder and when there is evidence that the disturbances are a 34direct physiological consequence34 of another medical condition substance intoxication or withdrawal toxin or various combinations of causes
While historically sometimes regarded as an inalterable consequence of disease delirium has been recognised as a significant contributor to both morbidity and even mortality in hospitalised patients especially in critically ill individuals who require intensive care Several risk factors for the development of delirium in intensive care units have been identified previously However many of these are factors not modifiable by caregivers eg advanced age frailty pre-existing cognitive impairment smoking alcohol consumption previous isolation etc While some aspects of environment and interventions especially endotracheal intubation use of physical restraints and sedation with benzodiazepines postoperative pain have been found to be strongly associated with the development of delirium assessment of the ICU environment itself as a potential modifiable risk factor is insufficient to this date
Intensive care is known to be associated with high noise levels attempts to reduce this noise pollution or provide protection from it may be worthwhile interventions to reduce delirium incidence However despite first attempts to establish associations between noise levels and delirium occurrence no target values for possible future interventions have been established yet
This study seeks to evaluate whether potentially modifiable environmental factors in intensive care units such as disturbances by noise or dazzling by light are associated with the development of delirium in critically ill patients 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 Such changes could potentially improve outcomes which would be much desired progress in delirium care where both non-pharmacologic and pharmacologic therapeutic approaches have not convincingly been shown to be of benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None