Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05140993 |
| Other study ID # |
0483-21 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
November 1, 2024 |
Study information
| Verified date |
June 2022 |
| Source |
Tel-Aviv Sourasky Medical Center |
| Contact |
Barak Cohen, MD |
| Phone |
+97236974093 |
| Email |
barakc[@]tlvmc.gov.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
