Clinical trial NCT02992717: Validation of the 3D-CAM to Detect Postoperative Delirium
Official title: Validation of the 3D-CAM in the Recovery Room to Detect Postoperative Delirium Compared to Nu-DESC, CAM and DSM-5 Criteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female adult patients undergoing elective general anaesthesia.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)
timeFrame: Up to three days
measure: Specificity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)
timeFrame: Up to three days
Secondary outcomes:
measure: Test Quality Level
timeFrame: Up to three days
measure: Duration of postoperative delirium
timeFrame: Up to three days
measure: Duration of stay in recovery room
timeFrame: Up to three days
measure: Duration of performance of the delirium testings
timeFrame: Up to three days
measure: Pain level
timeFrame: Participants will be followed up until the third postoperative day
measure: Postoperative complications
timeFrame: Up to three days
measure: Duration of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
measure: In-house mortality
timeFrame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
measure: Follow-up care
timeFrame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charite University, Berlin, Germany
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: Olbert M, Eckert S, Morgeli R, Kruppa J, Spies CD. Validation of 3-minute diagnostic interview for CAM-defined Delirium to detect postoperative delirium in the recovery room: A prospective diagnostic study. Eur J Anaesthesiol. 2019 Sep;36(9):683-687. doi: 10.1097/EJA.0000000000001048.