Postoperative DeliriumPOD-CARENCT04857125
Prevention of Postoperative Delirium After Acute Surgery
A study testing Patient interventions and Staff education in people with Postoperative Delirium, run by Bispebjerg Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Patient interventions and Staff education
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Apr 2021to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg and Frederiksberg Hospital
Copenhagen
sine.alette.nogel.eriksen.01@regionh.dk
About this study
Official title: Prevention of Delirium After Acute Surgery - Implementation of a Multicomponent Intervention Throughout the Hospitalization
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
- Being tested
- Patient interventions, Staff education
- Keywords
- Implementation, Prevention, Multicomponent intervention, Anaesthetics, General, Non-cardiac, Acute surgery, Non-pharmacological intervention, Postoperative care
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient interventionsOther
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 educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent intervention | Active comparator | Pre-, intra- and postoperative interventions applied using the Fast-IM method. Receives: Other: Patient interventions; Other: Staff education |
| Standard care | No intervention | Patients are receiving standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 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.
Measured: Patients are screened at time of arrival and until discharge from PACU
All-cause mortality within 30 days.
All-cause mortality
Measured: Day 30
Length of postoperative stay (LOS).
Length of postoperative stay in hospital
Measured: Day 30
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.
Measured: Day 30
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.
Measured: Day 30
Number of participants who are admitted to the intensive care unit after the operation.
Admission to the intensive care unit after the operation.
Measured: Day 30
Number of patients in need of re-operation
Need for re-operation due to complications
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start12 Apr 2021
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sine Eriksen, Bispebjerg Hospital
- Investigators
- Christian Meyhoff, MD, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857125
- Sponsor's protocol ID
- H-20067775
- Acronym
- POD-CARE
- Status last verified
- Apr 2021
- First submitted
- 4 Mar 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Delirium After Acute Surgery - Implementation of a Multicomponent Intervention Throughout the Hospitalization
- ClinicalTrials.gov ID
- NCT04857125
- Acronym / sponsor ID
- POD-CARE / H-20067775
- Conditions
- Postoperative Delirium
- Keywords
- Implementation, Prevention, Multicomponent intervention, Anaesthetics, General, Non-cardiac, Acute surgery, Non-pharmacological intervention, Postoperative care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent intervention | Active comparator | Other: Patient interventions, Other: Staff educationPre-, intra- and postoperative interventions applied using the Fast-IM method. |
| Standard care | No intervention | –Patients are receiving standard care. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient interventionsThe 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) | Other | Multicomponent intervention |
| Staff educationStaff 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. | Other | Multicomponent intervention |
Primary outcome
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).
7 secondary outcomes
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.
Time frame: Patients are screened at time of arrival and until discharge from PACU
All-cause mortality within 30 days.
Time frame: Day 30
Length of postoperative stay (LOS).
Time frame: Day 30
Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery.
Time frame: Day 30
Number of participants who are readmitted to hospital within 30 days.
Time frame: Day 30
Number of participants who are admitted to the intensive care unit after the operation.
Time frame: Day 30
Number of patients in need of re-operation
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
Related trials for Postoperative Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Meyhoff, MD, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient interventions and Staff education in people with Postoperative Delirium, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sine Eriksen, Cand. Cur. (+ 45 51920075, sine.alette.nogel.eriksen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.