Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients

Frailty Clinical Trial

Official title:

Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Single-center Prospective Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05189678
• Other study ID #: Frailty
• Status: Recruiting
• Start date: November 22, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2022
• Source: Qianfoshan Hospital
• Contact: Yongtao Sun, PhD
• Phone: 18660795201
• Email: sunyongtao1979[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients

2. Can the improved debilitating index predict the delusion after non-cardiac surgery

3. Which of the debilitating index are independent risk factors associated with postoperative delusions

Description:

Early identification of frailty patients is of great clinical significance for preoperative decision making and prognosis assessment. To date, the incidence of postoperative delirium in elderly patients undergoing noncardiac surgery has not been assessed. This study aimed to investigate the relationship between preoperative frailty assessment and the incidence of postoperative delirium after noncardiac surgery.

1. To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients

2. Can the improved debilitating index predict the delusion after non-cardiac surgery

3. Which of the debilitating index are independent risk factors associated with postoperative delusions

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: August 31, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age = 70 years old;

2. ASA: Grade ?~?;

3. Signed informed consent;

4. Scheduled non-cardiac surgery.

Exclusion Criteria:

1. Refuse to participate;

2. Expected length of stay <3 days;

3. The same patient can only be included once, regardless of whether the reason for the second operation is related to the first cause;

4. Emergency surgery patients;

5. Inability to communicate due to illiteracy, language impairment, severe hearing or visual impairment;

6. Central nervous system diseases, including various types of dementia and depression

7. Severe renal insufficiency (requiring dialysis treatment);

8. Severe liver dysfunction (Child-Pugh score =10);

9. Patients who have participated in other relevant clinical studies within 3 months MMSE examination has confirmed the existence of cognitive dysfunction: illiteracy =17 points, primary school degree =20 points, middle school degree (including technical secondary school) =22 points, university degree (including junior college) =23 points

Related Conditions & MeSH terms

• Delirium
• Frailty

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Yongtao Sun	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Gleason LJ, Benton EA, Alvarez-Nebreda ML, Weaver MJ, Harris MB, Javedan H. FRAIL Questionnaire Screening Tool and Short-Term Outcomes in Geriatric Fracture Patients. J Am Med Dir Assoc. 2017 Dec 1;18(12):1082-1086. doi: 10.1016/j.jamda.2017.07.005. Epub — View Citation

Kulason K, Nouchi R, Hoshikawa Y, Noda M, Okada Y, Kawashima R. Indication of Cognitive Change and Associated Risk Factor after Thoracic Surgery in the Elderly: A Pilot Study. Front Aging Neurosci. 2017 Dec 5;9:396. doi: 10.3389/fnagi.2017.00396. eCollect — View Citation

Woo J, Yu R, Wong M, Yeung F, Wong M, Lum C. Frailty Screening in the Community Using the FRAIL Scale. J Am Med Dir Assoc. 2015 May 1;16(5):412-9. doi: 10.1016/j.jamda.2015.01.087. Epub 2015 Feb 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Delirium	Incidence of postoperative delirium after noncardiac surgery.Postoperative delirium usually occurs between 24 hours and 72 hours after surgery, and this study will conduct follow-up assessments at six postoperative time points (once in the morning and afternoon on days 1 to 3 after surgery, 8:00 a.m.-10:00 a.m., 18:00-20:00 pm), as long as there was one time point to assess postoperative delirium, the patient was judged to have developed postoperative delirium.	Twice a day from day 1 to 3 after surgery (8:00-10:00 am and 18:00-20:00 PM).
Secondary	Incidence of 30-day readmission to hospital	Incidence of 30-day readmission to hospital	Within 30 days after surgery
Secondary	complications	Patients were followed up 30 days later for complications	Within 30 days after surgery