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.
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
- Conditions the study is for
- Perioperative Cardiavascular Complication, Peroperative Complication, Perioperative Pulmonary Complication
- 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.
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.
- Conditions
- Perioperative Cardiavascular Complication, Peroperative Complication, Perioperative Pulmonary Complication, Perioperative Neurological Complication
- 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.
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.
- First posted20 Jul 2021
- Study start1 Sep 2021
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative Cardiavascular ComplicationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ailin Luo
- Sponsor type
- University, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Beijing Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor-investigator, Ailin Luo, Tongji Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Management and Technical Measures and Evaluation Criteria for the Elderly During Perioperative Period
- ClinicalTrials.gov ID
- NCT04967872
- Acronym / sponsor ID
- TJ-IRB20210634
- Conditions
- Perioperative Cardiavascular Complication, Peroperative Complication, Perioperative Pulmonary Complication, Perioperative Neurological Complication
- Keywords
- the elderly population, frailty, perioperative visualization, perioperative ultrasound, perioperative monitoring, risk evaluation and prediction, sarcopenia, delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,782 participants (actual)
- Lead sponsor
- Ailin LuoUniversity, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Beijing Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 20 Jul 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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- selective surgery
- aged over 65-years-old.
Key exclusion criteria (3 listed)
- Participating in other clinical trials within 6 months
- Patients receiving local anesthesia
- Cases with unknown outcomes
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 |
|---|---|---|
| Implementing risk management and control plan for the elderly during perioperative periodVisualization 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 | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Derived from this study: PubMed 37921644Sun 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.