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NCT Number: NCT06268119

Effectiveness of Delirium Care Protocol After Cardiac Surgery

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.

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Key information

Conditions

Delirium, Postoperative Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Training and Research Hospital

Antalya, Center, 07000, Turkey (Türkiye)

About this study

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".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium.

Other

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.

Primary outcomes

  1. Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU)

    Time frame: Three weeks

    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.

Secondary outcomes

  1. Glasgow Coma Scale (GCS)

    Time frame: Three weeks

    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.

  2. Richmond Agitation-Sedation Scale (RASS)

    Time frame: Three weeks

    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.

  3. Information Assessment Form for Postoperative Delirium (Pretest-Posttest)

    Time frame: One week

    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.

Sponsors and collaborators

Lead sponsor

Gonul Kara Soylemez

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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