ORTOPOD PILOT STUDY is a non-randomized, non-interventional clinical study that addresses the issue of perioperative neurocognitive disorder (deterioration of cognitive functions in the preoperative and perioperative period) and its impact on the occurrence of postoperative delirium. Respondents meeting the entry criteria will undergo elective orthopaedic surgery (total hip arthroplasty) under general or regional anaesthesia.
ORTOPOD PILOT STUDY is a non-randomized, non-interventional clinical study that addresses the issue of perioperative neurocognitive disorder (deterioration of cognitive functions in the preoperative and perioperative period) and its impact on the occurrence of postoperative delirium. Respondents meeting the entry criteria will undergo elective orthopaedic surgery (total hip arthroplasty) under general or regional anaesthesia. Preoperatively, they will be examined using the ALBA and POBAV tests, which serve for rapid and indicative assessment of cognitive functions. Furthermore, the functional capacity of patients will be assessed using the Clinical Frailty Scale, and depression will be evaluated using the Geriatric Depression Scale (questionnaire). After the procedure, during hospitalization in the ICU/PACU, screening for postoperative delirium will be conducted using the CAM-ICU tool. The aim of the pilot study is to verify the methodology and obtain baseline data on the incidence of cognitive dysfunction, depression, and frailty preoperatively, as well as the incidence of postoperative delirium in this group of patients before submitting a grant to AZV ČR. The main research question will be whether preoperative cognitive decline (according to the ALBA and POBAV tests) is associated with the occurrence of postoperative delirium. The second research question will be what percentage of patients with preoperative cognitive deficit (according to the ALBA and POBAV tests) undergo elective total hip arthroplasty. Secondary outcomes will include whether there are differences in the ALBA and POBAV test results before and after surgery (cognitive decline after anesthesia and surgery), whether higher Clinical Frailty Scale scores are associated with the occurrence of postoperative delirium, and whether the results on the Geriatric Depression Scale change preoperatively and postoperatively.
Study Type
OBSERVATIONAL
Enrollment
75
Tomas Bata Hospital
Zlín, Czechia
ALBA - cognitive assessment preoperatively
Amnesia Light and Brief Assessment (ALBA) is an ultra-brief and universal cognitive test suitable for assessing cognitive impairment, dementia, and other conditions. Test consists of a one-time encoding of a six-word sentence "Indian summer brings the first morning frost.", sequential demonstration of six gestures and their immediate recall in any order (TEGEST) and finally recall of as many correct words as possible of the original sentence. The ALBA score norm for the sum of recalled words and gestures is 6-12 points (at least 50% of the maximum), mild impairment is 4-5 points, and severe impairment is 0-3 points. For more educated individuals (with a high school diploma or more, or 15 years of education or more), the ALBA score norm is 8-12 points..
Time frame: one week before surgery
POBAV - cognitive assessment preoperatively
POBAV is an abbreviationof Czech title Picture naming and their recall. The test consists of two parts. The persons are to name each of the 20 picture in one word and remember these picture names. When they finish naming the pictures, then they are asked to recall and write as many picture names as they can during one minute. Evaluation of Part 1: After completing the entire test, determine the number of naming errors (images not named at all and incorrectly named). Most older individuals should make a naming error in no more than one image. Evaluation of Part 2: The number of correctly recalled images will be determined. The number of errors from the total number of written picture names will be substracted to get the number of correctly recalled image names. Most older individuals should recall 6 or more correct image names, while individuals with a high school diploma should recall 7 image names.
Time frame: one week before surgery
Postoperative CAM-ICU
CAM-ICU scale: FEATURE 1: Alteration/Fluctuation in Mental Status - Present/not present FEATURE 2: Inattention 1: Alteration/Fluctuation in Mental Status -If number of errors \>2 = present /not present FEATURE 3: Altered Level of Consciousness (LOC) - present/not present FEATURE 4: Disorganized Thinking - present/not present Features 1 and 2 are both present and either Features 3 or 4 are present: Delirium present CAM-ICU is positive, delirium is present
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Time frame: 0. postoperative day, 1. postoperative day, 2. postoperative day.
ALBA, POBAV and CAM - ICU
The research question is: "Is the reduction in cognitive functions according to the ALBA and POBAV tests associated with the occurrence of postoperative delirium in the Czech Republic?
Time frame: one week before surgery,0. postoperative day, 1. postoperative day, 2. postoperative day.
Clinical frailty scale - assessment preoperatively
Clinical frailty scale is a way to summarize the overall level of fitness or frailty of an older adult after they had been evaluated by an experienced clinician. Frailty score ranging from 1 (very fit) to 9 (terminally ill). 1. = very fit 2. = well 3. = managing well 4. = vulnerable 5. = mildly frail 6. = moderately frail 7. = severely frail 8. = very severely frail 9. = terminally ill Research questions: Are higher values of the Clinical Frailty Scale before surgery (values 4, 5, or higher) associated with the occurrence of postoperative delirium in Czech Republic? Are higher values of the Clinical Frailty Scale before surgery (values 4, 5, or higher) associated with the worsening of cognitive functions
Time frame: one week before surgery
Age
Age of the patients undergoing elective tottal hip arthroplasty, in years.
Time frame: one week before surgery
ALBA - cognitive assessment postoperatively
Amnesia Light and Brief Assessment (ALBA) is an ultra-brief and universal cognitive test suitable for assessing cognitive impairment, dementia, and other conditions. Test consists of a one-time encoding of a six-word sentence "Indian summer brings the first morning frost.", sequential demonstration of six gestures and their immediate recall in any order (TEGEST) and finally recall of as many correct words as possible of the original sentence. The ALBA score norm for the sum of recalled words and gestures is 6-12 points (at least 50% of the maximum), mild impairment is 4-5 points, and severe impairment is 0-3 points. For more educated individuals (with a high school diploma or more, or 15 years of education or more), the ALBA score norm is 8-12 points..
Time frame: 3rd day after surgery
POBAV - cognitive assessment postoperatively
POBAV is an abbreviationof Czech title Picture naming and their recall. The test consists of two parts. The persons are to name each of the 20 picture in one word and remember these picture names. When they finish naming the pictures, then they are asked to recall and write as many picture names as they can during one minute. Evaluation of Part 1: After completing the entire test, determine the number of naming errors (images not named at all and incorrectly named). Most older individuals should make a naming error in no more than one image. Evaluation of Part 2: The number of correctly recalled images will be determined. The number of errors from the total number of written picture names will be substracted to get the number of correctly recalled image names. Most older individuals should recall 6 or more correct image names, while individuals with a high school diploma should recall 7 image names.
Time frame: 3rd day after surgery