AzTrials
AzTrials

Perioperative Cardiavascular ComplicationNCT04967872

Perioperative Management of Risk Factors in the Elderly Patients

A study of Perioperative Cardiavascular Complication and Peroperative Complication, run by Ailin Luo at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In 2017, the number of operations on hospitalized patients in China was more than 57 million, of which more than 20 million were performed on elderly patients (≥65 years of age). Read more about this study

Who is it for?
Ages 65 years and older
How many people
4,782 participants
Where
1 siteChina
Study dates
1 Sep 2021to 31 Mar 2024
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • selective surgery
  • aged over 65-years-old.

Who cannot join

  • Participating in other clinical trials within 6 months
  • Patients receiving local anesthesia
  • Cases with unknown outcomes

Trial locations and contacts

1 site in 1 country.

China1 site
  • TongjiHospital

    Wuhan

Other trials in China

About this study

Official title: Risk Management and Technical Measures and Evaluation Criteria for the Elderly During Perioperative Period

In 2017, the number of operations on hospitalized patients in China was more than 57 million, of which more than 20 million were performed on elderly patients (≥65 years of age). As of the end of 2017, there were 143 million elderly people over 65 years old in China, of which 26 million people were 80 years old and over, accounting for 1.8% of the country's total population, and this proportion is increasing. More and more elderly patients need surgery. A study showed that compared with the 65-79-year-old population, the probability of myocardial infarction after orthopedic surgery in patients over 80 years of age increased by 2.7 times, the probability of lung infection increased by 3.5 times, and the mortality rate increased by 3.4 times. The inherent risks of surgery and increased postoperative complications in elderly patients are closely related to factors such as senile syndrome.

Geriatric syndrome refers to the deterioration of the function of various organ systems as the age increases, and a series of non-specific symptoms and signs appear in the elderly, including weakness, comorbidities, cognitive dysfunction and so on. These symptoms increase with age, seriously impairing the quality of life of the elderly and increasing their perioperative risk. Taking frailty as an example, the incidence of frailty among the 65-70 years old population is 3.2%, 71-74 years old is 5.3%, 75-79 years old is 9.5%, 80-84 years old is 16.3%, and> 85 years old is 25.1. %. On the other hand, the physical functions of the elderly are constantly degrading with age. Take skeletal muscle as an example. After the age of 50, the skeletal muscle mass decreases by 1%-2% every year with the increase of age. The chronic muscle loss of people over 60 years old is estimated to be 30%, and the elderly people over 80 years old lose up to 50%. It can be seen that the elderly patients are a special group of elderly patients, which have their particularity compared with the low-age elderly groups. Therefore, the establishment of a perioperative risk warning and control system and technical system for elderly patients to deal with the unpredictable perioperative risks caused by their weakness, comorbidities, and physical hypofunction, and to provide safety guarantees for elderly surgical patients has become an urgent problem for geriatrics.

Read the detailed description

Enhanced recovery after surgery (ERAS) is based on evidence-based medicine and optimizes the clinical path of perioperative management through the collaboration of multiple departments. The core is patient-centered promotion of rehabilitation. This concept is deeply rooted in the hearts of the people. In this context, the center intends to use the high incidence of hip fractures and lung cancer in elderly patients as a breakthrough, and combine the center's domestic leading visualization technology and artificial intelligence (AI) technology to create a complete perioperative evaluation system for elderly patients to reduce the perioperative risk of elderly patients.

In the context of perioperative risk control, our primary goal is to comprehensively identify potential risk factors through systematic analysis of their relationships with postoperative complications. We meticulously document patients' underlying conditions, comorbidities, laboratory test results, and imaging findings, while also using a variety of scales to perform a preoperative evaluation. These scales include the Activities of Daily Living (Barthel Index), Insomnia Severity Index (ISI), Stop-Bang score, FRAIL scale, Mini Nutritional Assessment (MNA), Mini-Cog for cognitive performance, as well as the Amsterdam Preoperative Anxiety and Information Scale (APAIS) for anxiety assessment and the Geriatric Depression Scale (GDS). Additionally, we employ the ARISCAT (Catalonian Surgical Patients' Pulmonary Risk Assessment) and the Revised Cardiac Risk Index (RCRI) to further delineate surgical risk. During the surgical process, we meticulously record details of the operation and anesthesia, including anesthetic drugs, intraoperative monitoring, and vital signs; postoperatively, we identify cardiovascular, pulmonary, and neurological complications based on established standards. Through this comprehensive approach, we can identify the relevant risk factors present in both the preoperative and intraoperative phases, thereby enabling effective control and management of perioperative risks.

Visualization techniques include visualization of airway tools, ultrasound visualization, and visualization of brain function monitoring, etc., which are widely used in preoperative risk assessment, bedside rapid assessment, airway management, auxiliary vascular puncture, guided regional block anesthesia, postoperative analgesia, etc. Links, and achieved good clinical results. These technologies have their own advantages, but lack systematic integration and targeted optimization. Organically integrate various visualization technologies suitable for elderly patients to create a complete perioperative evaluation system for elderly patients, comprehensive and real-time dynamic evaluation of patients, and realize the perioperative mental, neurological, respiratory, and circulatory functions of elderly patients Precise management reduces the stress and damage of important organs (such as heart, lung, brain, kidney, etc.), achieves the holistic management of elderly patients during the perioperative period, and reduces the risk of elderly patients during the perioperative period.

Artificial intelligence technology can deeply mine medical big data, integrate a large amount of complex data and have powerful comprehensive analysis functions. It is suitable for assisting elderly patients with complex preoperative evaluation, perioperative medical decision-making, and real-time warning of unpredictable adverse events. This technology has been widely used in various medical fields, including tumor imaging diagnosis, skin disease diagnosis, diabetes diagnosis, etc. At present, foreign scholars have combined the relevant clinical characteristics of patients and used artificial intelligence technology to develop an early warning system for intraoperative hypotension, a real-time early warning system for monitoring the death risk of inpatients, and an in-hospital cardiac arrest prediction system. Artificial intelligence is used to comprehensively assess and predict perioperative risks and real-time early warning, which will cover the entire perioperative period of elderly patients and implement effective risk control.

The inherent risks of surgery and postoperative complications of elderly patients increase. To deal with the unpredictable perioperative risks caused by their weakness, comorbidities, and hypofunction, providing safety guarantees for elderly surgical patients has become a major issue in geriatrics. This project uses visualization technology for preoperative evaluation, anesthesia management, bedside real-time monitoring and intervention, etc., to achieve accurate perioperative management of elderly patients and whole-process whole-person management. AI technology is applied to perioperative risk prediction of elderly patients and real-time follow-up risk warning to guide the control of the depth of anesthesia and the maintenance of organ function. The above technologies are organically integrated around the various situations that increase the perioperative risk of elderly patients, and embedded in the closed loop of evaluation-diagnosis-intervention-re-evaluation to create a complete perioperative evaluation system for elderly patients. And through a multi-disciplinary team to optimize the clinical path of perioperative management, to demonstrate the whole-person risk management system for elderly patients during the perioperative period for further promotion.

Being tested
Implementing risk management and control plan for the elderly during perioperative period
Keywords
the elderly population, frailty, perioperative visualization, perioperative ultrasound, perioperative monitoring, risk evaluation and prediction, sarcopenia, delirium, acute kidney injury, pneumonia, acute myocardial injury
Medical subject headings
Intraoperative Complications, Frailty, Sarcopenia, Delirium, Acute Kidney Injury, Pneumonia

What participants receive

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

  • Implementing risk management and control plan for the elderly during perioperative periodOther

    Visualization technology is used for preoperative evaluation, anesthesia management, bedside real-time monitoring and intervention, etc., to achieve accurate perioperative management of elderly patients and whole-process whole-person management

What is being measured

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

  1. The incidence of perioperative adverse events in elderly patients

    Measured: From the beginning of anesthesia induction to 30 days after surgery or discharged of hospital

Timeline

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

  1. First posted20 Jul 2021
  2. Study start1 Sep 2021
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,782 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04967872
Sponsor's protocol ID
TJ-IRB20210634
Status last verified
Mar 2024
First submitted
8 Jul 2021
Last updated
15 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sun R, Zhou Z, Li X, Xu Q, Zhou B, Yu H, Zhang W, Sun Q, Zhang X, Luo X, Li S, Luo A. Prognostic significance of preoperative nutritional status for postoperative acute kidney injury in older patients undergoing major abdominal surgery: a retrospective cohort study. Int J Surg. 2024 Feb 1;110(2):873-883. doi: 10.1097/JS9.0000000000000861.

    PubMed 37921644

Questions about this trial

What is this clinical trial studying?

A study of Perioperative Cardiavascular Complication and Peroperative Complication, run by Ailin Luo at 1 site in China.

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 3 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: finished, as of the sponsor's last update on 15 Apr 2025. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of perioperative adverse events in elderly patients (time frame: From the beginning of anesthesia induction to 30 days after surgery or discharged of hospital). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04967872, which also lists 1 linked publication.

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 15 Apr 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in