Delirium Prevention Guideline for Intensive Care Patients

Not Applicable

Not yet recruiting

• Conditions: Delirium; Nurse's Role
• Interventions: Other: Delirium Prevention Guideline

• Registration Number: NCT06403410
• Lead Sponsor: Istanbul Demiroglu Bilim University

Brief Summary

Delirium is a complication characterized by fluctuations in orientation, memory, thinking, or behavior, with sudden onset of these changes. Studies have shown that pharmacological agents are the most significant risk factors for delirium in intensive care units. In recent years, the impact of non-pharmacological interventions in preventing delirium development has started to be discussed.

Detailed Description

Delirium is a complication characterized by fluctuations in orientation, memory, thinking, or behavior, with a sudden onset of these changes. Increased mortality and prolonged hospital stay have been identified in patients diagnosed with delirium. Advanced age, underlying urinary or respiratory tract infection, and existing cognitive impairment increase the risk of delirium development. Studies have shown that pharmacological agents are the most significant risk factors for delirium in intensive care units. However, environmental factors such as sound, continuous light, odors, invasive and non-invasive interventions, sensory overload, lack of meaningful verbal and cognitive stimuli, social isolation, immobilization, sleep disorders, temperature, drafts, and absence of windows in the environment are also indicated to contribute to delirium development. The presence of tubes, urinary catheters, invasive procedures, mechanical ventilation, and retention in the patient also increases the risk. In treatment, early detection and prevention of risk factors are prioritized. In case of development, efforts are made to prevent delirium-related complications and reduce its duration through pharmacological and non-pharmacological interventions. However, although many studies have been conducted on the prevention of delirium development with numerous pharmacological agents, a clear conclusion has not yet been reached. Pharmacological agents are generally used to alleviate symptoms. In recent years, the impact of non-pharmacological interventions in preventing delirium development has started to be discussed. Non-pharmacological interventions used in delirium prevention, as published by the National Institute for Health and Care Excellence (NICE), are itemized as pain management, prevention of dehydration, early mobilization, infection control, regulation of medications, sleep hygiene, and patient orientation. NICE also emphasizes the necessity of using a validated tool for assessing delirium.

A meta-analysis study has been published examining non-pharmacological interventions aimed at reducing the incidence of delirium, with a total of 26 studies included. According to this study, the methods that reduce the incidence are, respectively; family involvement, exercise program, multiple interventions (occupational therapy, reorientation, sleep therapy, music, etc.), ensuring cerebral hemodynamics, arranging the physical environment, and applying a sedation protocol. When the studies are examined, it is seen that efforts focus on ensuring sleep hygiene, maintaining patient orientation, and eliminating factors in the physical environment that may disrupt patient comfort. Evidence suggests strategies such as optimizing the environment, controlling light and noise, grouping patient care activities, and taking appropriate measures to preserve patients' sleep cycles to promote sleep regulation in adult ICU patients (Evidence: +1C). In the literature, studies have been conducted on the use of earplugs to protect ICU patients from noise and using eye masks to reduce exposure to light to ensure sleep hygiene. Delirium prevention strategies to be implemented should be compatible with clinical workflow. The method to be used should be easily adapted by all team members and patient relatives, and should be encouraged for use in clinical protocol. Collaboration between physicians, nurses, and patient relatives is essential in preventing delirium development. The pharmacological dimension of preventive interventions can be carried out by physicians, while non-pharmacological interventions can be implemented through collaboration between nurses and patient relatives. In this study, we aimed to determine the effect of guideline usage and team collaboration on the frequency of delirium development.

Study Timeline

• Study First Submitted: 2024-04-26
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Study First Posted: 2024-05-07
• Last Update Posted: 2024-05-07
• Study Start: 2024-06-15
• Primary Completion: 2024-09-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Aged 18 and above,
• Without motor, sensory, or hearing impairment,
• Able to communicate,
• Admitted to the intensive care unit within the first 24 hours of admission,
• Without chronic cerebral damage,
• Richmond Agitation Sedation Scale value between -1 and +1 at the beginning of the study,
• Nursing Delirium Screening Scale (Nu-DESC) score <2,
• No wounds or infections in the ears or eyes,
• Patients who have given consent to participate in the study.

Exclusion Criteria

• Patients who receive sedation or require sedation during the data collection process, those who are unable to communicate due to intubation, those with diagnosed psychiatric disorders, those with profound hearing loss affecting communication, and those who do not wish to use eye masks and earplugs will be excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Delirium Prevention Guideline	In the intervention group, initially, the Patient Identification Form, RASS, and Nu-DESC will be administered. The RASS and Nu-DESC forms will continue to be applied once a day throughout the patient's follow-up period in the intensive care unit, every 12 hours. Each intervention group patient randomized will receive the Delirium Prevention Guideline. The guideline includes standard practices used by intensive care nurses in patient monitoring. In addition to routine follow-ups, eye masks and earplugs will be applied to patients in the intervention group between 24:00 and 06:00. It is expected that the guideline will be used once every 24 hours, in the morning, to ensure standardization

Primary Outcome Measures

Name	Time	Method
In patients receiving Delirium Prevention Guidelines, the rate of delirium development is change compared to the control group at the end of one week.	3 weeks	prevent delirium

Trial Locations

Locations (1)

Demiroğlu Bilim University; 🇹🇷 İstanbul, Şişli, Turkey