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NCT Number: NCT02992717

Validation of the 3D-CAM to Detect Postoperative Delirium

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).

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charite University, Berlin, Germany

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensitivity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)

    Time frame: 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

  2. Specificity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)

    Time frame: 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 outcomes

  1. Test Quality Level

    Time frame: Up to three days

    Comparison of test Quality level between 3D-CAM, Nu-DESC and CAM to detect POD in the recovery room.

  2. Duration of postoperative delirium

    Time frame: Up to three days

  3. Duration of stay in recovery room

    Time frame: Up to three days

  4. Duration of performance of the delirium testings

    Time frame: Up to three days

  5. Pain level

    Time frame: Participants will be followed up until the third postoperative day

  6. Postoperative complications

    Time frame: Up to three days

    Postoperative complications according to Clavien-Dindo classification

  7. Duration of hospital stay

    Time frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks

  8. In-house mortality

    Time frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks

  9. Follow-up care

    Time frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Validation of the 3D-CAM in the Recovery Room to Detect Postoperative Delirium Compared to Nu-DESC, CAM and DSM-5 Criteria

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2016
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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