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Prevention of Postoperative Delirium After Acute Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04857125
Acronym
POD-CARE
Enrollment
476
Registered
2021-04-23
Start date
2021-04-12
Completion date
2022-03-31
Last updated
2021-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Keywords

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

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.

Interventions

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.

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)

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The statistician will be blinded from the groups, when assessing the primary outcome.

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 PACUPatients 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.
All-cause mortality within 30 days.Day 30All-cause mortality
Length of postoperative stay (LOS).Day 30Length of postoperative stay in hospital
Number of participants who are readmitted to hospital within 30 days.Day 30Re-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.
Number of participants who are admitted to the intensive care unit after the operation.Day 30Admission to the intensive care unit after the operation.
Number of patients in need of re-operationDay 30Need for re-operation due to complications
Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery.Day 30Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery after surgery will be assessed.

Other

MeasureTime frameDescription
Percentage of staff who have received trainingThis 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.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.

Countries

Denmark

Contacts

Primary ContactSine Eriksen, Cand. Cur.
sine.alette.nogel.eriksen.01@regionh.dk+ 45 51920075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026