FrailtyNCT05189678
Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients
An observational study of Frailty, run by Qianfoshan Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Frailty
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients older than 70 years undergoing non-cardiac surgery
Who may be able to join
- Age ≥ 70 years old;
- ASA: Grade Ⅰ～Ⅳ;
- Signed informed consent；
- Scheduled non-cardiac surgery.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yongtao Sun
Jinan, Shandong, 250000
Yongtao Sun, doctor, 18660795201, sunyongtao1979@163.com
About this study
Official title: Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Single-center Prospective Observational Cohort Study
- To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients
- Can the improved debilitating index predict the delusion after non-cardiac surgery
- Which of the debilitating index are independent risk factors associated with postoperative delusions
Read the 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.
- To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients
- Can the improved debilitating index predict the delusion after non-cardiac surgery
- Which of the debilitating index are independent risk factors associated with postoperative delusions
- Conditions
- Frailty
- Being tested
- No intervention
- Keywords
- Frailty POD
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| frailty group | Modified Frailty index score greater than or equal to 0.21 Receives: Other: No intervention | |
| non-frailty group | Modified Frailty index score is less than 0.21 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Incidence of 30-day readmission to hospital
Measured: Within 30 days after surgery
complications
Patients were followed up 30 days later for complications
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start22 Nov 2021
- Primary completion30 May 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Yuelan Wang, PhD, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189678
- Sponsor's protocol ID
- Frailty
- Status last verified
- Jan 2022
- First submitted
- 13 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29259553Woo 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.
PubMed 25732832Gleason 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.
PubMed 28866353Zhang 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.
PubMed 39166961Zhang 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.
PubMed 38446754
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Single-center Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05189678
- Acronym / sponsor ID
- Frailty
- Conditions
- Frailty
- Keywords
- Frailty POD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients
- Can the improved debilitating index predict the delusion after non-cardiac surgery
- 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.
- To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients
- Can the improved debilitating index predict the delusion after non-cardiac surgery
- Which of the debilitating index are independent risk factors associated with postoperative delusions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| frailty group | – | Other: No interventionModified Frailty index score greater than or equal to 0.21 |
| non-frailty group | – | Other: No interventionModified Frailty index score is less than 0.21 |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients older than 70 years undergoing non-cardiac surgery
Key inclusion criteria (4 listed)
- Age ≥ 70 years old;
- ASA: Grade Ⅰ～Ⅳ;
- Signed informed consent；
- Scheduled non-cardiac surgery.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | frailty group, non-frailty group |
Primary outcome
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.
2 secondary outcomes
Incidence of 30-day readmission to hospital
Time frame: Within 30 days after surgery
complications
Time frame: Within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Results publication: PubMed 29259553Kulason 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.
- Results publication: PubMed 25732832Woo 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.
- Results publication: PubMed 28866353Gleason 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.
- Derived from this study: PubMed 39166961Zhang 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.
- Derived from this study: PubMed 38446754Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuelan Wang, PhD principal investigator
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongtao Sun, PhD (18660795201, sunyongtao1979@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05189678, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.