Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients

NCT05189678 | Unknown

• 1 other identifier: Frailty
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients
2. 2.Can the improved debilitating index predict the delusion after non-cardiac surgery
3. 3.Which of the debilitating index are independent risk factors associated with postoperative delusions

Conditions

Frailty

Keywords

Frailty POD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of 30-day readmission to hospital

  Within 30 days after surgery

• complications

  Within 30 days after surgery

Study Arms (2)

frailty group

Modified Frailty index score greater than or equal to 0.21

Other: No intervention

non-frailty group

Modified Frailty index score is less than 0.21

Other: No intervention

Interventions

No intervention OTHER

No intervention

frailty group; non-frailty group

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 70 years undergoing non-cardiac surgery

You may qualify if:

• Age ≥ 70 years old;
• ASA: Grade Ⅰ～Ⅳ;
• Signed informed consent；
• Scheduled non-cardiac surgery.

You may not qualify if:

• Refuse to participate;
• Expected length of stay \<3 days;
• The same patient can only be included once, regardless of whether the reason for the second operation is related to the first cause;
• Emergency surgery patients;
• Inability to communicate due to illiteracy, language impairment, severe hearing or visual impairment;
• Central nervous system diseases, including various types of dementia and depression
• Severe renal insufficiency (requiring dialysis treatment);
• Severe liver dysfunction (Child-Pugh score ≥10);
• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Yongtao Sun

Jinan, Shandong, 250000, China

RECRUITING

Related Publications (5)

• 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. eCollection 2017.

  PMID: 29259553 RESULT

• 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.

  PMID: 25732832 RESULT

• 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 2017 Aug 31.

  PMID: 28866353 RESULT

• Zhang M, Gao X, Liu M, Gao Z, Guo Y, Chen L, Liu Y, Zhang X, Huang L, Tong M, Zou T, Sun Y. Correlation of preoperative frailty with postoperative delirium and 1-year mortality in Chinese geriatric patients undergoing non-cardiac surgery: a prospective observational cohort study. Int J Surg. 2025 Jan 1;111(1):1576-1579. doi: 10.1097/JS9.0000000000002042. No abstract available.

  PMID: 39166961 DERIVED

• Zhang M, Gao X, Liu M, Gao Z, Sun X, Huang L, Zou T, Guo Y, Chen L, Liu Y, Zhang X, Feng H, Wang Y, Sun Y. Correlation of preoperative frailty with postoperative delirium and one-year mortality in Chinese geriatric patients undergoing noncardiac surgery: Study protocol for a prospective observational cohort study. PLoS One. 2024 Mar 6;19(3):e0295500. doi: 10.1371/journal.pone.0295500. eCollection 2024.

  PMID: 38446754 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuelan Wang, PhD

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongtao Sun, PhD

CONTACT

18660795201; sunyongtao1979@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 12, 2022
• Study Start: November 22, 2021
• Primary Completion: May 30, 2022
• Study Completion: August 31, 2022
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)