Prevention of Postoperative Delirium After Acute Surgery

Postoperative Delirium Clinical Trial

— POD-CARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857125
• Other study ID #: H-20067775
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: March 2022

Study information

• Verified date: April 2021
• Source: Bispebjerg Hospital
• Contact: Sine Eriksen, Cand. Cur.
• Phone: + 45 51920075
• Email: sine.alette.nogel.eriksen.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 476
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Other:
• Patient interventions
The multicomponent intervention consists of several elements regarding avoidance of specific pre-medications and optimising the patients condition before surgery (reducing fasting and fluid-fasting time). Per-operative focus on using bispectral index (BIS) guided anaesthesia, Total intravenous anaesthesia (TIVA) as first choice, pain-and PONV (postoperative nausea and vomiting) prophylaxis and treatment. Postoperative focus on: Reducing indwelling catheters, Fluid (p.o. or IV), Nutrition, Mobilisation, Sleep, Non-pharmacological interventions (Shielding, involving of relatives, orientation, optimizing of senses)
• Staff education
Staff will be educated for at least 1-2 hours. Anaesthesiologist and nurse anaesthetists will receive a brush up on the use of bispectral index (BIS) and the intervention elements that are implemented and monitored. Staff in the PACU, as well as staff in the surgery wards, will be educated in postoperative delirium, learning to identify symptoms of delirium and how to use the screening tool CAM.

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of staff who have received training	It will be registered how many of the staff have received the training, the target being 80%. Staff participation in the training will be registred, and the sessions repeated during the 6 months, until 80% of the staff, or more, have recieved the training.	This outcome will be evaluated from when the implementation period starts and until it finishes. The length of this period is 6 months. Staff participation in the training will be registred, and the sessions repeated during the 6 months.
Primary	Postoperative delirium identified with the screening tool Confusion Assessment Method (CAM), assessing change from negative to positive score.	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).	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).
Secondary	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 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.	Patients are screened at time of arrival and until discharge from PACU
Secondary	All-cause mortality within 30 days.	All-cause mortality	Day 30
Secondary	Length of postoperative stay (LOS).	Length of postoperative stay in hospital	Day 30
Secondary	Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery.	Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery after surgery will be assessed.	Day 30
Secondary	Number of participants who are readmitted to hospital within 30 days.	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.	Day 30
Secondary	Number of participants who are admitted to the intensive care unit after the operation.	Admission to the intensive care unit after the operation.	Day 30
Secondary	Number of patients in need of re-operation	Need for re-operation due to complications	Day 30