Clinical trial NCT06036017: Care Bundle's Impact on Delirium Prevention in CABG Patients
Official title: Determining the Effect of Care Package Implementation in Preventing Delirium in Patients Undergoing Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium
Bypass Complication
Coronary Artery Bypass
Patient Care Bundles
Keywords: Coronary Artery Bypass Graft Surgery
Care bundle Application
Delirium Prevention
Postoperative Care
Cardiac Surgery
Intensive Care
Quality of Care
music
Lead sponsor: Kilis 7 Aralik University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: During T0 assessment, the TBF (Total Body Function), GCS (Glasgow Coma Scale), GKO (Glasgow-Koma Ölçeği), RCUO (Respiratory Care Unit Observation), RASS (Richmond Agitation-Sedation Scale), and CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) forms will be completed for both groups of patients, and blood samples will be taken. During T1 assessment, the GCS, GKO, RCUO, RASS, and CAM-ICU forms will be completed for both groups of patients, and blood samples will be taken. Additionally, the duration of anesthesia, intubation, and sedation, as well as the amount of sedative drugs used, will be noted. The care package prepared for the study group will be applied by nurses working in the ward.At T2, the GCS, GKO, RCUO, RASS, and CAM-ICU forms will be completed for both groups of patients, and blood samples will be taken. The duration of stay in the intensive care unit will also be recorded.
Primary purpose: PREVENTION

Brief summary: This research investigates the effectiveness of a care package used in the care of patients undergoing coronary artery bypass graft (CABG) surgery in preventing postoperative delirium. CABG surgery is a common procedure used to increase blood flow to the heart and is typically applied in patients with severe cardiac diseases. However, this procedure can increase the risk of postoperative delirium, especially among elderly and critically ill patients.

In this study, the goal is to reduce this risk by implementing a care package. The care package includes optimal pain management, sleep regulation, mobilization, ensuring patient orientation, and appropriate medication management.

The results of the research will be used to determine whether the use of this care package is effective in reducing the risk of delirium after CABG surgery. This could potentially improve patient outcomes and allow for more efficient use of hospital resources.

Detailed description: Open-heart surgery is an effective treatment method used in the treatment of heart diseases today. However, after this operation, patients are at risk of postoperative delirium, which negatively affects the patient's recovery process. Open-heart surgery is a commonly performed surgical procedure; despite technological advancements and improvements in hospital care, delirium after open-heart surgery remains a common complicationDelirium, a condition causing acute dysfunction in the brain, leads to changes in patients' mental states and impairments in cognitive functions. Delirium after open-heart surgery is a common complication and can increase the patient's morbidity and mortality. Delirium extends the hospital stay and increases patient care costs. Therefore, it is important to implement a special care package to reduce the risk of delirium. The frequency of delirium in patients undergoing open-heart surgery varies between 20% and 50%. The post-open-heart surgery delirium prevention care package is a series of practices designed to reduce the patient's delirium risk. These practices may include; maintaining a regular sleep pattern, noise control, balancing hormone levels, family proximity, and music therapy.

Antipsychotic drugs, a pharmacological agent, are commonly used in the treatment of delirium. These drugs help to alleviate the symptoms of delirium and make the patient more calm. However, antipsychotic drugs are effective in symptom management and their side effects worsen the patient's condition and the effectiveness of antipsychotic drugs on delirium is doubtful. It is extremely important to avoid routine application of antipsychotic drugs. Instead, non-pharmacological methods are preferred, such as providing a suitable environment, regulating noise and light levels, maintaining sleep patterns, increasing physical activity, preventing unnecessary drug use, and regulating fluid and electrolyte balance. These methods can reduce the risk of delirium and help the patient undergo a faster and more successful recovery process.

There is a significant place in the literature for non-pharmacological methods for the prevention of delirium. These methods include ensuring the suitability of the environment the patient is in, regulating sleep schedules, keeping noise and light levels under control, psychological support and rehabilitation, pain and symptom management, prevention of sensory disorders, reducing invasive procedures, increasing physical activity, encouraging sleep, preventing unnecessary drug use, family-centered care, regulating fluid and electrolyte balance, and arranging nutritional order. The implementation of these methods can help avoid delirium risk factors and contribute to a faster recovery process for the patient.

Delirium is a very distressing condition for family members, especially those who observe delirium attacks. This situation can also have lasting effects on patients who remember delirium attacks in the hospital. It can also cause difficulties for the healthcare personnel caring for these patients. Therefore, it is extremely important to take the best possible precautions against delirium attacks or to treat the disease.

Family-centered care is an important factor in reducing the risk of delirium in patients during the postoperative period. Family members can be by the patients' side, provide moral support, and help patients feel more peaceful and comfortable in the postoperative period. Family members' support can reduce the patient's delirium risk, as it helps the patient maintain a familiar environment. A support network can also be critical in observing symptoms of delirium and ensuring appropriate treatment is sought.

Involvement of family members in patient care can be beneficial in many ways. For example, they can help orient the patient to time, place, and situation, provide emotional support, and communicate the patient's needs and preferences to the healthcare team. They can also encourage the patient to engage in physical activity, eat, and drink, which can help maintain their overall health and well-being.

Music therapy, one of the non-pharmacological methods, is also known to be effective in preventing delirium after open-heart surgery. Music therapy can help to reduce anxiety and promote relaxation, both of which can aid in delirium prevention.

In addition to these, maintaining a regular sleep pattern, controlling noise levels, and balancing hormone levels can be very effective in reducing the risk of delirium. Disruptions in sleep can lead to a higher risk of delirium, so ensuring the patient has a quiet and calm environment for rest can be crucial.

In conclusion, prevention of delirium after open-heart surgery is vital for the successful recovery of patients. A multi-faceted approach that includes non-pharmacological interventions such as environmental modifications, family-centered care, music therapy, and maintaining a regular sleep pattern, in addition to pharmacological treatments when necessary, is likely to be most effective. Further research is needed to identify the most beneficial and feasible interventions for preventing delirium after open-heart surgery.

Eligibility criteria: Inclusion Criteria:

Participants and Sample Criteria Inclusion criteria for the study:

* Over 18 years of age,
* Considered as a low-risk group according to American Society of Anesthesiologists (ASA)
* I-II and EUROSCORE scores
* Undergoing open-heart surgery for the first time
* Having an operation with on-pump and median sternotomy technique,
* Mild and moderate hypothermia applied,
* One to three coronary artery bypass grafts performed,
* Left internal mammary artery and saphenous vein graft applied,
* Surgery initiated between 08:00-12:00 hours,
* Having no psychiatric diagnosis and therefore no drug therapy,
* Not using corticosteroid derivative drugs,
* No complications observed that may affect the surgery and ICU process,
* Having a family member who can support the patient in the postoperative wake-up process,
* Patients who voluntarily agree to participate in the research will be included.

Exclusion Criteria:

* Extended surgery due to complications,
* Completion of the intraoperative process falls into the evening hours (after 16:00),
* Consciousness level after extubation prevents participation in the study (Glasgow Coma Score \<15),
* Corticosteroid derivative drugs applied at any stage of the perioperative process, Surgery is canceled,
* No family member is available to stay in the intensive care unit,
* Wishing to withdraw from the research at any stage after voluntarily agreeing to participate in the study,
* At any stage of the research, patients who do not wish to use earplugs or listen to music and wish to withdraw from the research, their data will be excluded from the study.

Primary outcomes:
measure: 1.Introductory Information Form
timeFrame: up to 12 months
measure: 2.Glasgow Coma Scale (GCS)
timeFrame: up to 12 months
measure: Visual Analogue Scale (VAS)
timeFrame: up to 12 months
measure: Richard-Campbell Sleep Scale (RCSS):
timeFrame: up to 12 months
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: up to 12 months
measure: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU):
timeFrame: up to 12 months
measure: Maintenance Package Checklist:
timeFrame: up to 12 months
measure: Delirium Preventive Care Package Compliance Schedule
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kilis
country: Turkey
facility: Islam
Study officials:
affiliation: kilis 7 Aralik Univ.
name: İslam Elagoz, Ress. ass.
role: STUDY_CHAIR
References: