Postoperative Delirium
Conditions
Brief summary
The 3D-CAM is a new 3-minute diagnostic assessment for Confusion Assessment Method-defined Delirium. The primary objective of this study is to translate the 3D-CAM into the German language, as well as to validate its use to detect postoperative delirium in the recovery room. The validation will be based on comparisons to the Nu-DESC (Nursing Delirium Screening Scale), CAM (Confusion Assessment Method), and DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders).
Detailed description
Approximately 200 patients will be enrolled in the study. They will followed up until the third postoperative day. Calculation and analysis of demographic and perioperative influencing factors on postoperative delirium according to routine parameters (age, sex, body height, body weight, diagnosis, physical status according to the American Society of Anaesthesiologists (ASA PS), duration of surgery, Physiological and Operative Severity Score (POSSUM), type of anesthesia, medication against pain and delirium) will be performed.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients with age ≥ 18 years * Admission to recovery room (RR) or post anaesthesia care unit (PACU) following elective general anaesthesia and scheduled * Inpatient treatment not less than 24 hours.
Exclusion criteria
* Patients with psychiatric diseases and mental retardation * Analphabetism * Anacusis or Hypoacusis with hearing aid device, * Amaurosis * Lacking willingness to save and hand out data within the study * Accommodation in an institution due to an official or judicial order * Patients with unability speaking German or English language * Participation in other clinical studies during the study period * Coworker in the study site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the delirium screening/diagnosing tool 3D Confusion Assessment Method (3D-CAM) | Up to three days | Sensitivity of the delirium screening/diagnosing tool 3D Confusion Assessment Method (3D-CAM) to detect postoperative delirium (POD) in the recovery room - Used reference standard: DSM-5 criteria |
| Specificity of the delirium screening/diagnosing tool 3D Confusion Assessment Method (3D-CAM) | Up to three days | Specificity of the delirium screening/diagnosing tool 3D Confusion Assessment Method (3D-CAM) to detect postoperative delirium (POD) in the recovery room - Used reference standard: DSM-5 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of stay in recovery room | Up to three days | — |
| Duration of performance of the delirium testings | Up to three days | — |
| Pain level | Participants will be followed up until the third postoperative day | — |
| Test Quality Level | Up to three days | Comparison of test Quality level between 3D-CAM, Nu-DESC and CAM to detect POD in the recovery room. |
| Duration of hospital stay | Participants will be followed for the duration of hospital stay an expected average of 3 weeks | — |
| In-house mortality | Participants will be followed for the duration of hospital stay an expected average of 3 weeks | — |
| Follow-up care | Participants will be followed for the duration of hospital stay an expected average of 3 weeks | — |
| Postoperative complications | Up to three days | Postoperative complications according to Clavien-Dindo classification |
| Duration of postoperative delirium | Up to three days | — |
Countries
Germany
Outcome results
None listed