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Postoperative DeliriumNCT05140993

The Role of Emotional and Orientation Support in Prevention of Postoperative Delirium Among Elderly Surgical Patients

A study testing extended emotional and orientation support in people with Postoperative Delirium, run by Barak Cohen, MD at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Postoperative delirium is common and associated with significant adverse outcomes. Its etiology is unknown, and little is known about associated risk factors. The investigatorea aim to test whether providing emotional and orientation support can reduce the risk of postoperative delirium in elderly patients undergoing… Read more about this study

Who is it for?
Ages 70 to 120 years
Conditions the study is for
Postoperative Delirium
What is being tested?
extended emotional and orientation support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
1 siteIsrael
Study dates
1 Jun 2022to 1 Nov 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 70 to 120 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • age ≥ 70 years
  • having non-cardiac and non-cranial surgery in the Tel-Aviv Medical Center

Who cannot join

  • Known psychiatric or severe neurologic disorder (e.g., Alzheimer's disease, past stroke)
  • Preoperative cognitive decline (MiniCog test result < 3 points)
  • Not planned to be extubated and awaken at surgery conclusion
  • Known inability to cooperate with postoperative delirium screening (language barrier, aphasia)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Barak Cohen, MD contact

+97236974093

barakc@tlvmc.gov.il

Yuval Baar, MSc contact

+97236974093

yuvalba@tlvmc.gov.il

Israel1 site, 1 recruiting
  • Division of Anesthesiology, Intensive Care Medicine and Pain management, Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel

    Tel Aviv

    Barak Cohen, MD

    Recruiting

Other trials in Israel

About this study

Official title: The Role of Emotional and Orientation Support in Prevention of Postoperative Delirium Among Elderly Surgical Patients - a Multiple-crossover Clinical Trial

Postoperative delirium is common and associated with significant adverse outcomes. Its etiology is unknown, and little is known about associated risk factors. The investigatorea aim to test whether providing emotional and orientation support can reduce the risk of postoperative delirium in elderly patients undergoing elective non-cardiac surgery. Specifically, the investigators will test whether allowing such patients to keep their hearing and visual aids and be escorted into the operating room by a family member until anesthesia induction reduces the incidence of postoperative delirium. Delirium will be actively screened as part of our institution's clinical practice starting at PACU admission and for a minimum of 2 postoperative days. The investigators will use a multiple cross-over design to enroll all eligible patients and alternate between the intervention and our common practice (removing sensorial aids in the preoperative area and not allowing patients' escort beyond that point) every 2 weeks for up to 2 years.

Read the detailed description

The world population is constantly growing older, and life expectancy in the western world is well over 80 years. The older population suffers more severe comorbidities, yet needs more surgical care. Anesthesiologists and surgeons are therefore required to care for older and sicker patients, often undergoing longer and more complex procedures than in the past.

Delirium is one of the most common adverse events experienced by hospitalized elderly patients. It is defined as an acute and fluctuating state characterized by altered awareness, behavior, emotional state, or thinking, and is associated with other morbidities as well as with mortality. Postoperative delirium (POD) affects between 10% and 50% of elderly surgical patients, depending on patients' baseline morbidities, the type of surgical procedure, and the tools and criteria used for diagnosis. POD is certainly the most common postoperative complication in this patient population, and is strongly associated with other postoperative adverse outcomes and mortality. Many societies and task-forces now recommend routine screening for cognitive decline and delirium in the perioperative period.

Several risk factors have been identified to be independently associated with POD, such as age, sex, and preoperative cognitive level. Nonetheless, most of the known risk factors are not modifiable, and little is known regarding interventions that can potentially decrease the risk of POD.

The division of Anesthesia and Intensive Care in the Tel-Aviv Medical Center has been conducting a quality improvement project since 2019, in which all surgical patients 70 years or older having elective non-cardiac non-cranial surgery are screened postoperatively for POD using the validated 4A's test starting in the post-anesthesia care unit (PACU) and for at least two postoperative days. The participants are also screened for preoperative cognitive decline, and monitored for other significant postoperative adverse events. Nearly 2000 eligible patients have been analyzed to date.

POD incidence in our institution is over 14%, and the investigators found a strong association between preoperative cognitive decline and POD, as also demonstrated by others. Interestingly, the investigators also demonstrated a strong association between delirium diagnosis in PACU and a later diagnosis in the surgical ward, suggesting that screening for delirium as early as PACU admission is important.

Many caregivers feel that the cognitive and emotional state in which patients are during induction of general anesthesia has a great impact on their immediate recovery. Frail and elderly patients are probably even more sensitive to this effect. Our common clinical routine while caring for adult surgical patients is to have a family member or friend escorting patients into the preoperative admission area, but not into the operating room. Similarly, our nursing practice includes the removal of hearing and visual aids prior to entry into the operating room. Since older patients are more prone to POD, the negative impact of separating them from their emotional and orientation support is presumably significant. In contrast, it is very common to have a family member escorting pediatric patients into the operating room and supporting them until anesthesia induction. The investigators previously conducted a pilot feasibility project in which the investigators allowed a family member of 50 elderly patients to escort them into the operating room. The investigators found that the process is feasible and simple. Moreover, all participants were satisfied and reported that they would be happy to use such an option in the future, and no family member was overwhelmed or had any adverse event as a consequence of entering the operating room.

The investigators therefore wish to test the hypothesis that allowing patients 70 years or older having non-cardiac non-cranial surgery to enter the operating room escorted by a supporting person and keeping their hearing and visual aids until anesthesia induction reduces the incidence of postoperative delirium during the initial two postoperative days.

Postoperative delirium is the most common postoperative complication in the elderly population, and has major impact on length of hospitalization, and postoperative morbidity and mortality. There are currently no known preventive interventions to reduce this risk. The investigators suggest a simple and safe logistic institutional intervention that can potentially reduce this risk.

Objectives

To test whether emotional and orientation support provided to surgical patients over 70 years of age reduces the incidence of postoperative delirium during the initial 2 postoperative days.

Research questions:

Are patients ≥ 70 years having non-cardiac non-cranial surgery who are being escorted into the operating room by a supporting person and keeping their hearing and visual aids, at reduced risk of postoperative delirium during the initial two postoperative days, compared to the clinical routine of separating patients from such emotional and orientation support before entry into the operating room?

Primary aim - to test the hypothesis that providing elderly surgical patients with emotional and orientation support until anesthesia induction reduces the risk of postoperative delirium, compared to the clinical routine of removing such support in the preoperative admission area.

Methods and Measurements

The investigators suggest a single-center, open-label, multiple-crossover trial in which all eligible patients will be enrolled, and the intervention (providing extended emotional and orientation support) will be altered every two weeks against the control, which is the current clinical practice.

Being tested
extended emotional and orientation support
Medical subject headings
Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • extended emotional and orientation supportBehavioural

    extended emotional and orientation support

Study groups in NCT05140993
Study groupRoleWhat they receive
extended supportExperimentalproviding extended emotional and orientation support
Receives: Behavioral: extended emotional and orientation support
common practiceNo interventionThe hospital routine clinical standard- not providing extended emotional and orientation support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of postoperative delirium

    A composite outcome of postoperative delirium, consisting of at least of the following - a positive 4A's test, positive 3D-CAM test, or delirium symptoms described in the nursing notes.

    Measured: Up to 30 postoperative days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2021
  2. Study start1 Jun 2022
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 Nov 2025 (estimated)

Resources

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
Randomised
Intervention model
Crossover
Model description
suggest a single-center, open-label, multiple-crossover trial in which all eligible patients will be enrolled, and the intervention (providing extended emotional and orientation support) will be altered every two weeks against the control, which is the current clinical practice.
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05140993
Sponsor's protocol ID
0483-21
Status last verified
Nov 2024
First submitted
29 Sep 2021
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing extended emotional and orientation support in people with Postoperative Delirium, run by Barak Cohen, MD at 1 site in Israel.

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 2 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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. 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 Israel. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Barak Cohen, MD (+97236974093, barakc@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative delirium (time frame: Up to 30 postoperative days). 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 20 Nov 2024.

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