NCT04967872

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,782

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 15, 2025

Status Verified

March 1, 2024

Enrollment Period

2.6 years

First QC Date

July 8, 2021

Last Update Submit

April 10, 2025

Conditions

Keywords

the elderly populationfrailtyperioperative visualizationperioperative ultrasoundperioperative monitoringrisk evaluation and predictionsarcopeniadeliriumacute kidney injurypneumoniaacute myocardial injury

Outcome Measures

Primary Outcomes (1)

  • The incidence of perioperative adverse events in elderly patients

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

Interventions

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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TongjiHospital

Wuhan, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Intraoperative ComplicationsFrailtySarcopeniaDeliriumAcute Kidney InjuryPneumonia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsConfusionNeurobehavioral ManifestationsNeurocognitive DisordersMental DisordersRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 20, 2021

Study Start

September 1, 2021

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 15, 2025

Record last verified: 2024-03

Locations