Prevention of Postoperative Delirium After Acute Surgery

Not Applicable

• Conditions: Postoperative Delirium
• Interventions: Other: Patient interventions; Other: Staff education

• Registration Number: NCT04857125
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

The aim of this trial is to evaluate the implementation and effect of an evidence based, multicomponent intervention on postoperative delirium, when fast implemented throughout the patients stay in hospital before, during and after acute surgery in a risk population, the primary outcome being frequency of patients with positive Confusion Assessment Method (CAM) score.

The hypothesis is that the frequency of postoperative delirium will be reduced after implementation of the preventive interventions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-04
• Status Verified: 2021-04
• Study Start: 2021-04-12
• Study First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Study First Posted: 2021-04-23
• Last Update Posted: 2021-04-23
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

• Patients aged 40 or above.
• Patients scheduled for acute abdominal or orthopaedic surgery in general anaesthesia with an expected duration of 30 minutes or more.
• Patients who are scheduled for surgery within 72 hours of hospital admission.
• Patients who are expected to stay in hospital for 24 hours or more.

Exclusion Criteria

• Patients screened CAM positive before surgery.
• Patients who have already been included in the study
• Patients unable to speak and read Danish.
• Inability to provide consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multicomponent intervention	Staff education	Pre-, intra- and postoperative interventions applied using the Fast-IM method.
Multicomponent intervention	Patient interventions	Pre-, intra- and postoperative interventions applied using the Fast-IM method.

Primary Outcome Measures

Name	Time	Method
Postoperative delirium identified with the screening tool Confusion Assessment Method (CAM), assessing change from negative to positive score.	During the 5 initial postoperative in-hospital days. Patients are screened twice a day; in the morning (7-10 AM) and in the evening (7-11 PM).	Patients are screened with the tool Confusion Assessment Method (CAM). A patient will be considered CAM positive, according to the CAM algorithm for diagnosis of delirium that requires the presence of both the first (acute onset and fluctuating course) and the second criteria (inattention) and of either the third (disorganised thinking) or the fourth criterion (altered level of consciousness).

Secondary Outcome Measures

Name	Time	Method
Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery.	Day 30	Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery after surgery will be assessed.
All-cause mortality within 30 days.	Day 30	All-cause mortality
Number of participants who are admitted to the intensive care unit after the operation.	Day 30	Admission to the intensive care unit after the operation.
Number of patients in need of re-operation	Day 30	Need for re-operation due to complications
Length of postoperative stay (LOS).	Day 30	Length of postoperative stay in hospital
Number of participants who are readmitted to hospital within 30 days.	Day 30	Re-admissions are defined as an acute admission which takes place between 4 hours and 30 days after discharge from hospital. The readmission indicator is non-specific, as all readmissions are included, regardless of which hospital the readmission takes place and regardless of the diagnosis at readmission.
Inadequate emergence identified with the screening tool Confusion Assessment Method (CAM) in the Post-Anaesthesia Care Unit (PACU), assessing change from negative to positive score.	Patients are screened at time of arrival and until discharge from PACU	Patients are screened with the tool Confusion Assessment Method (CAM) in the Post-Anaesthesia Care Unit (PACU). A patient will be considered CAM positive, according to the CAM algorithm for diagnosis of delirium that requires the presence of both the first (acute onset and fluctuating course) and the second criteria (inattention) and of either the third (disorganised thinking) or the fourth criterion (altered level of consciousness). A positive CAM score at any time during the PACU stay is considered as having "Inadequate emergence", assessing change from negative to positive score.

Trial Locations

Locations (1)

Bispebjerg and Frederiksberg Hospital; 🇩🇰 Copenhagen, Denmark