Effectiveness of Delirium Care Protocol After Cardiac Surgery

Delirium, Postoperative Clinical Trial

Official title:

Effectiveness of Postoperative Delirium Prevention, Diagnosis and Intervention Protocol on Patients Monitored in the Intensive Care Unit After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06268119
• Other study ID #: MustafaKU-SBF-GKS-01
• Status: Completed
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: May 22, 2023

Study information

• Verified date: February 2024
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery.

Description:

This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery. The research was conducted at Antalya Training and Research Hospital between 06.03.2023 and 22.05.2023. The sample of the study consisted of 64 patients who underwent cardiac surgery and met the inclusion criteria. Within the scope of the study, patients were divided into two groups: control (32) and intervention (32). While the patients in the intervention group received care in line with the "Postoperative delirium prevention, diagnosis and intervention protocol", the patients in the control group received routine nursing care for delirium. The data of the study were collected using the Patient Identification Form, Acute Physiological and Chronic Health Evaluation, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Confusion Assessment Scale in the Intensive Care Unit, Nurse Diagnosis Form, Information Assessment Form for Postoperative Delirium (Pretest-Posttest) and Postoperative Delirium Prevention, Diagnosis and Intervention Protocol Checklist. In the first stage of the study, which consisted of three stages, the incidence of delirium in the control group patients receiving routine nursing care and the delirium diagnosis status of the nurses were determined. In the second stage, nurses were given training on postoperative delirium prevention, diagnosis and intervention protocol, and a preliminary study of the protocol was conducted. In the third phase, which is the last phase, patients in the intervention group received care in line with the "Postoperative Delirium Prevention, Diagnosis and Intervention Protocol".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 22, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Volunteering to participate in the study,

• Being 18 years or older,

• Ability to speak and communicate in Turkish,

• Having undergone cardiac surgery and being on the first postoperative day,

• Richmond Agitation and Sedation Scale (RASS) score of -3 and above,

• Having a Glasgow Coma Scale (GCS) score of 8 and above,

• Not having a serious psychiatric or neurological diagnosis,

• No serious visual or auditory problems

Exclusion Criteria:

• Undergoing surgeries other than cardiac surgery (such as abdominal endovascular aneurysm repair, thoracic endovascular aneurysm repair, deep vein thrombosis, peripheral artery disease, carotid endarterectomy),

• Previous cardiac surgery,

• Postponing or canceling the surgery,

• No preoperative admission to the cardiovascular surgery service and no emergency surgery.

Related Conditions & MeSH terms

• Delirium
• Delirium, Postoperative

Intervention

Other:
• training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium.
The intervention group received care in line with the postoperative delirium prevention, diagnosis and intervention protocol after the delirium training given by the researcher to intensive care unit nurses.

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital	Antalya	Center

Sponsors (1)

Lead Sponsor	Collaborator
Gonul Kara Soylemez

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594. Erratum In: Eur J Anaesthesiol. 2018 Sep;35(9):718-719. — View Citation

Allen SR, Frankel HL. Postoperative complications: delirium. Surg Clin North Am. 2012 Apr;92(2):409-31, x. doi: 10.1016/j.suc.2012.01.012. — View Citation

Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012. — View Citation

Hshieh TT, Inouye SK, Oh ES. Delirium in the Elderly. Clin Geriatr Med. 2020 May;36(2):183-199. doi: 10.1016/j.cger.2019.11.001. — View Citation

Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU)	With the application of CAM-ICU, an evaluation is made as "there is delirium" or "there is no delirium". CAM-ICU; It consists of four items including sudden change of consciousness or fluctuation in the patient's level of consciousness, attention assessment, and evaluation of thought organization and level of consciousness. According to this scale, in order for patients to be diagnosed with delirium, the first and second items and one of the third or fourth items must result in favor of delirium.	Three weeks
Secondary	Glasgow Coma Scale (GCS)	It is used to evaluate the patients' state of consciousness. With a scale consisting of three parts: eye opening, motor and verbal response, the patients' response to stimuli in these three areas is evaluated and scored. It is evaluated between three and fifteen points, with fifteen points indicating full consciousness and three points indicating deep coma. In order for CAM-ICU to be applied to patients, the GCS score must be eight or above. If the GCS score is eight or below, the patient is considered to be in a coma and cannot be evaluated.	Three weeks
Secondary	Richmond Agitation-Sedation Scale (RASS)	Before starting the delirium evaluation, the state of consciousness (alertness) is first evaluated. RASS takes values between "(+4)" and "(-5)". While the ideal level where the patient is alert and calm is scored as "0" on the scale, positive RASS scores "(+1,+2,+3,+4)" indicate an agitated patient; Negative RASS scores "(-1,-2,-3,-4,-5)" indicate patients who are sedated or in a coma.	Three weeks
Secondary	Information Assessment Form for Postoperative Delirium (Pretest-Posttest)	The knowledge assessment form for postoperative delirium (Pretest-Posttest) was developed by researchers by scanning the literature in order to measure the knowledge levels of nurses working in intensive care units before and after training on postoperative delirium. For each item in the form consisting of 30 questions, answers were received from the participants as "True", "False" and "I don't know". "1" point was given for each "True" statement, and "0" point was given for each "False" and "I don't know" statements. The highest score that can be obtained from the test is "30". The form, consisting of items regarding the definition of delirium, risk factors, symptoms, prevention, diagnosis and intervention of delirium, was applied by the researcher to all nurses who attended the training before and after the training.	One week