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Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients

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ClinicalTrials.gov Identifier: NCT05189678
Recruitment Status : Recruiting
First Posted : January 12, 2022
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Lili Cao, Qianfoshan Hospital

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

Condition or disease Intervention/treatment
Frailty Other: No intervention

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

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Single-center Prospective Observational Cohort Study
Actual Study Start Date : November 22, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
frailty group
Modified Frailty index score greater than or equal to 0.21
Other: No intervention
No intervention

non-frailty group
Modified Frailty index score is less than 0.21
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Postoperative Delirium [ Time Frame: Twice a day from day 1 to 3 after surgery (8:00-10:00 am and 18:00-20:00 PM). ]
    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.


Secondary Outcome Measures :
  1. Incidence of 30-day readmission to hospital [ Time Frame: Within 30 days after surgery ]
    Incidence of 30-day readmission to hospital

  2. complications [ Time Frame: Within 30 days after surgery ]
    Patients were followed up 30 days later for complications



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Ages Eligible for Study:   70 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients older than 70 years undergoing non-cardiac surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05189678


Contacts
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Contact: Yongtao Sun, PhD 18660795201 sunyongtao1979@163.com

Locations
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China, Shandong
Yongtao Sun Recruiting
Jinan, Shandong, China, 250000
Contact: Yongtao Sun, doctor    18660795201    sunyongtao1979@163.com   
Sponsors and Collaborators
Qianfoshan Hospital
Investigators
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Principal Investigator: Yuelan Wang, PhD The First Affiliated Hospital of Shandong First Medical University
Publications of Results:
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Responsible Party: Lili Cao, Professor, Qianfoshan Hospital
ClinicalTrials.gov Identifier: NCT05189678    
Other Study ID Numbers: Frailty
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lili Cao, Qianfoshan Hospital:
Frailty POD
Additional relevant MeSH terms:
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Delirium
Frailty
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes