Light and Noise: Objectively Assessing Environmental Risk Factors for Delirium in the ICU

NCT06294158 | Recruiting

• 1 other identifier: LANYARD-ICU-1.1
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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 (i.e., risk factors).

Conditions

Delirium; Critical Illness

Keywords

Delirium; Critical Illness; Light; Noise

Outcome Measures

Primary Outcomes (1)

• Delirium

  Development of delirium, i.e., positive CAM-ICU examination

  7 days

Study Arms (1)

Observation Cohort

Adult patients (age ≥ 18 years) admitted to to participating Intensive Care Units with an expected (further) stay in participating Intensive Care Unit ≥ 48 hours who are not (currently) deeply sedated (RASS ≥ -3) and are not already in delirium (CAM-ICU positive), do not require environmental modification due to treatment necessities (e.g., burns care), and do not have advanced directives or treatment limitation orders in place, in whom environmental light and noise are measured.

Other: Brightness measurement; Other: Sound level measurement

Interventions

Brightness measurement OTHER

Measurement of ambience brightness using lux meters

Observation Cohort

Sound level measurement OTHER

Measurement of ambience sound levels using sound level meters

Observation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients shall be included into the study if they can be expected to remain in the ICU for at least another two days, if they are not yet in delirium, if the ICU environment is not actively modified for therapeutic reasons (e.g., in the treatment of burns patients), if no treatment limitations are in place and if the patient can provide written informed consent. In those patients, who cannot provide informed consent upon recruitment due to their current illness or injury, consent by patients or their representatives shall be sought if and once they regain capacity (deferred consent).

You may qualify if:

• Adult patients (age ≥ 18 years)
• Admission to participating Intensive Care Unit
• Expected (further) stay in participating Intensive Care Unit ≥ 48 hours

You may not qualify if:

• Patient already in delirium (CAM-ICU positive)
• Environmental modification due to treatment necessities (e.g., burns care)
• Advanced directives / Treatment limitation
• Documented patient refusal in advance

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

University Medical Centre Graz, Dept. of Anaesthesiology and Intensive Care Medicine

Graz, Styria, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Delirium; Critical Illness

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Central Study Contacts

Paul Zajic, MD PhD

CONTACT

+43 316 385 0; paul.zajic@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

AU (1)