Tomas Bata Hospital
Zlín, 76001, Czechia
NCT Number: NCT06869876
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.
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Notify Me65 year and older
All sexes
Observational
Zlín, 76001, Czechia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: one week before surgery
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 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: 0. postoperative day, 1. postoperative day, 2. postoperative day.
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
Time frame: one week before surgery,0. postoperative day, 1. postoperative day, 2. postoperative day.
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
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).
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 of the patients undergoing elective tottal hip arthroplasty, in years.
Time frame: 3rd day after surgery
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 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
Gender of the patient undergoing elective total hip arhroplasty. Women or men.
Time frame: one week before surgery
The American Society of Anesthesiologists (ASA) physical status classification system is a grading system to determine the health of a person before a surgical procedure that requires anesthesia ASA I = a normal healthy patient ASA II = a patient with mild systematic disease ASA III = a patient with severe systematic disease
Time frame: one week before surgery
The Geriatric Depression Scale (GDS) is a self-report measure of depression in older adults. Users respond in a "Yes/No" format. Scoring: 0 or 1 point (1 point is awarded for the presence of a depressive symptom). 10 questions indicate depression when answered "Yes," and 5 questions (Nos. 1, 5, 7, 11, 13) indicate depression when answered "No." The questionnaire can thus score a maximum of 15 points.0-5 normal mood, 6-10 mild depression, 11+ severe depression
Time frame: one week before surgery
Education of the patients in years.
Time frame: end of the operation
Cumulatively in minutes. time will be indicated according to the operating protocol
Time frame: end of the operation
Blood pressure values at the beginning and end of the procedure, in mmHg (in anesthesia record).
Hypotension blood pressure 30% lower than baseline pressure, reported cumulatively in minutes.
Time frame: end of the operation
Value at the beginning and end of the procedure (%), desaturation yes/no (Spo2 94 and less%), duration (in minutes).
Time frame: end of the operation
Blood loss cumulative for the procedure in milliliters.
Time frame: end of the operation
Sample of blood glucose level taken as part of standard practice, mmol/l.
Time frame: end of the operation
Yes or no. Yes when it is necessary to administer norepinephrine or ephedrine.
Time frame: end of the operation
Highest dose of noradrenaline during operation, in µg/kg/min. Total duration of norepinephrine administration during surgery in minutes).
Time frame: 3rd day after operation
Cumulatively in milliliters, during the CAM-ICU screening period (postoperative day 0, postoperative day 1, postoperative day 2). In case of CAM-ICU positivity, the blood loss assessment continues during the CAM-ICU screening period. Blood loss assessment once a day.
Evaluated will be amount of transfusion units and , Types of blood derivatives given: Deleukocytized erythrocytes, Prothrombin Complex Concentrate (PCC), Pathogen-inactivated plasma, Fresh frozen plasma, fibrinogen, Platelets from buffy coat mixed deleukocytized in replacement solution.
Time frame: 0. postoperative day
Yes or no. Assessment 0. postoperative day.
Time frame: 3rd day after operation
Yes or no. During the CAM-ICU screening period (postoperative day 0, postoperative day 1, postoperative day 2.
Time frame: 3rd day after operation
Yes or no. Y (yes=when it is necessary to administer norepinephrine). During the CAM-ICU screening period (postoperative day 0, postoperative day 1, postoperative day 2.
Time frame: 3rd day after operation
Highest dose of noradrenaline during the day, in µg/kg/min. Total duration of norepinephrine administration after the procedure (in minutes). During the CAM-ICU screening period (postoperative day 0, postoperative day 1, postoperative day 2).
Time frame: 3rd day after operation
Yes or no.
Tomas Bata Hospital, Czech Republic
Other
Ortopod CZ Pilot Study (Total Knee Arthoplasty and Postoperative Delirium Czech Republic
Acronym: ORTOPODCZ
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