Clinical trial NCT06869876: Ortopod CZ Pilot Study
Official title: Ortopod CZ Pilot Study (Total Knee Arthoplasty and Postoperative Delirium Czech Republic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Delirium (POD)
Perioperative Neurocognitive Disorders
Keywords: postoperative delirium
CAM- ICU
ALBA
POBAV
Amnesia Light and Brief Assessment,
screening
cognitive assessment
risk factors
seniors
Lead sponsor: Tomas Bata Hospital, Czech Republic
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: "Respondents meeting the entry criteria will undergo elective orthopedic surgery (total hip replacement) under general or regional anesthesia.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age over 65 years (inclusive)

  * Type of procedure: elective hip replacement (TEP) under general or regional anesthesia
* ASA classification I-III
* Absence of sensory impairment (blindness, deafness, deaf-blindness)

Exclusion Criteria:

* Glasgow Coma Scale of 14 or less
* Limited legal capacity
* Known psychiatric illness with the use of psychiatric medications
* Effect of premedication, psychiatric, and analgesic sedative drugs (at the time of cognitive function testing)
* Active oncological disease
* Chronic use of strong opioids
* Re-operation

Primary outcomes:
measure: ALBA - cognitive assessment preoperatively
timeFrame: one week before surgery
measure: POBAV - cognitive assessment preoperatively
timeFrame: one week before surgery
measure: Postoperative CAM-ICU
timeFrame: 0. postoperative day, 1. postoperative day, 2. postoperative day.
measure: ALBA, POBAV and CAM - ICU
timeFrame: one week before surgery,0. postoperative day, 1. postoperative day, 2. postoperative day.
Secondary outcomes:
measure: Clinical frailty scale - assessment preoperatively
timeFrame: one week before surgery
measure: Age
timeFrame: one week before surgery
measure: ALBA - cognitive assessment postoperatively
timeFrame: 3rd day after surgery
measure: POBAV - cognitive assessment postoperatively
timeFrame: 3rd day after surgery
Other outcomes:
measure: Gender
timeFrame: one week before surgery
measure: ASA status preoperatively
timeFrame: one week before surgery
measure: The Geriatric Depression Scale (GDS)
timeFrame: one week before surgery
measure: Education
timeFrame: one week before surgery
measure: Duration time of the operation
timeFrame: end of the operation
measure: Blood pressure value during surgery
timeFrame: end of the operation
measure: Spo2 during surgery
timeFrame: end of the operation
measure: Blood loss during surgery
timeFrame: end of the operation
measure: Blood glucose level during surgery
timeFrame: end of the operation
measure: Circulatory instability during surgery
timeFrame: end of the operation
measure: Norepinephrine during surgery
timeFrame: end of the operation
measure: Blood loss after the procedure
timeFrame: 3rd day after operation
measure: Postoperative nausea and vomiting
timeFrame: 0. postoperative day
measure: Administered hypnotic or/and anxiolytic
timeFrame: 3rd day after operation
measure: Circulatory instability after the procedure
timeFrame: 3rd day after operation
measure: Norepinephrine after the procedure
timeFrame: 3rd day after operation
measure: Necessity of re-operation within 3 days
timeFrame: 3rd day after operation
Locations:
city: Zlín
country: Czechia
facility: Tomas Bata Hospital
Study officials:
References: