Clinical trial NCT05189678: Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients
Official title: Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Single-center Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
Keywords: Frailty POD
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 1
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 70 years undergoing non-cardiac surgery

Brief 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

Detailed 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

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 70 years old;
2. ASA: Grade Ⅰ～Ⅳ;
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

Primary outcomes:
measure: Postoperative Delirium
timeFrame: Twice a day from day 1 to 3 after surgery (8:00-10:00 am and 18:00-20:00 PM).
Secondary outcomes:
measure: Incidence of 30-day readmission to hospital
timeFrame: Within 30 days after surgery
measure: complications
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Yongtao Sun
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Yuelan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. eCollection 2017.
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.
citation: 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.