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Clinical Trials/NCT04857125
NCT04857125
Unknown
Not Applicable

Prevention of Delirium After Acute Surgery - Implementation of a Multicomponent Intervention Throughout the Hospitalization

Bispebjerg Hospital1 site in 1 country476 target enrollmentApril 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Delirium
Sponsor
Bispebjerg Hospital
Enrollment
476
Locations
1
Primary Endpoint
Postoperative delirium identified with the screening tool Confusion Assessment Method (CAM), assessing change from negative to positive score.
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 12, 2021
End Date
March 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sine Eriksen

Principal Investigator

Bispebjerg Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Postoperative delirium identified with the screening tool Confusion Assessment Method (CAM), assessing change from negative to positive score.

Time Frame: 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 Outcomes

  • Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery.(Day 30)
  • All-cause mortality within 30 days.(Day 30)
  • Number of participants who are admitted to the intensive care unit after the operation.(Day 30)
  • Number of patients in need of re-operation(Day 30)
  • Length of postoperative stay (LOS).(Day 30)
  • Number of participants who are readmitted to hospital within 30 days.(Day 30)
  • 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)

Study Sites (1)

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