CompletedNot Applicable

Ortopod CZ Pilot Study

Czechia75 participantsStarted 2025-03-01

Plain-language 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.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

ALBA - cognitive assessment preoperatively

Timeframe: one week before surgery

POBAV - cognitive assessment preoperatively

Timeframe: one week before surgery

Postoperative CAM-ICU

Timeframe: 0. postoperative day, 1. postoperative day, 2. postoperative day.

ALBA, POBAV and CAM - ICU

Timeframe: one week before surgery,0. postoperative day, 1. postoperative day, 2. postoperative day.

Trial details

NCT IDNCT06869876

SponsorTomas Bata Hospital, Czech Republic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-22

View on ClinicalTrials.gov More Postoperative Delirium (POD) trials