Prevention of Postoperative Delirium After Acute Surgery

NCT04857125 | Unknown DMC

• 1 other identifier: H-20067775
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Keywords

Implementation; Prevention; Multicomponent intervention; Anaesthetics, General; Non-cardiac; Acute surgery; Non-pharmacological intervention; Postoperative care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• All-cause mortality within 30 days.

  Day 30

• Length of postoperative stay (LOS).

  Day 30

• Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery.

  Day 30

• Number of participants who are readmitted to hospital within 30 days.

  Day 30

Other Outcomes (1)

• Percentage of staff who have received 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.

Study Arms (2)

Multicomponent intervention

ACTIVE COMPARATOR

Pre-, intra- and postoperative interventions applied using the Fast-IM method.

Other: Patient interventions; Other: Staff education

Standard care

NO INTERVENTION

Patients are receiving standard care.

Interventions

Patient interventions OTHER

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)

Multicomponent intervention

Staff education OTHER

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.

Multicomponent intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg and Frederiksberg Hospital

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Christian Meyhoff, MD, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sine Eriksen, Cand. Cur.

CONTACT

+ 45 51920075; sine.alette.nogel.eriksen.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded from the groups, when assessing the primary outcome.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: April 23, 2021
• Study Start: April 12, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

DK (1)