Clinical trial NCT06268119: Effectiveness of Delirium Care Protocol After Cardiac Surgery
Official title: Effectiveness of Postoperative Delirium Prevention, Diagnosis and Intervention Protocol on Patients Monitored in the Intensive Care Unit After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium, Postoperative
Keywords: delirium
cardiac surgery
nursing
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The control group received standard care. The intervention group received care in line with postoperative delirium prevention, diagnosis, and intervention.
Primary purpose: PREVENTION

Brief 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.

Detailed 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".

Eligibility criteria: 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.

Primary outcomes:
measure: Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU)
timeFrame: Three weeks
Secondary outcomes:
measure: Glasgow Coma Scale (GCS)
timeFrame: Three weeks
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: Three weeks
measure: Information Assessment Form for Postoperative Delirium (Pretest-Posttest)
timeFrame: One week
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
state: Center
Study officials:
affiliation: Mustafa Kemal University
name: Gonul Kara Soylemez, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.