Frail Elderly SyndromeNCT05078983
Investigation of Relation With Preoperative Fragility and ASA Score in Elderly Patients
An observational study of Frail Elderly Syndrome and Muscle Weakness, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Frailty is a term specific to the geriatric period. It is used to describe weak, unstable, frail patients and partially expresses the frailty of the elderly patient. Once the frailty process begins, the risk of loss of mobility, dependency and mortality increases. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Muscle Weakness
- What is being tested?
- CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)
- How many people
- 320 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2021to 17 Nov 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 65 years and older
- All sexes
- Older adult
Study population: Patients over the age of 65 who were admitted to the general surgery service for surgery and then operated.
Who may be able to join
- Patients over the age of 65 who were admitted to the general surgery service for surgery and then operated.
Who cannot join
- -Patients with advanced stage dementia
Trial locations and contacts
1 site in 1 country.
About this study
Frailty is a term specific to the geriatric period. It is used to describe weak, unstable, frail patients and partially expresses the frailty of the elderly patient. Once the frailty process begins, the risk of loss of mobility, dependency and mortality increases.
Frailty is an important predictor of adverse outcomes after surgery. According to studies conducted in various surgical situations, fragility is a major risk factor for morbidity, mortality and longer hospital stay. According to the available data, frailty has a sufficient basis for determining the risks of patients before surgery, developing preventive methods and making personal treatment decisions. As the frailty index increased, it was observed that the duration of postoperative hospital stay was associated with the need for intensive care, postoperative complications, and the rate of re-admissions within 30 days.
Read more
ASA (American Society of Anesthesiologists) classification is widely used in order to evaluate the physical condition preoperatively in geriatric individuals with multiple comorbidities. Considering the fragility variable while creating the ASA score in the preoperative period may be useful in determining the follow-up strategy during the operation and postoperative period. For example, a patient who is evaluated as ASA 2 because he has no problems other than simple 1-2 comorbid conditions, involuntary weakening of 5% in the last 1 year (not easily noticed), weakness (can only be detected with a dynamometer) and cessation of going out of the house (can only be understood when asked privately). ) can be categorized as at risk at ASA level 3-4, as it is understood to be fragile.
The aim of this project is to examine the frequency of frailty in elderly individuals who will be operated on, and to examine the relationship between frailty and ASA score using the anthropometry and comorbidity differences between frail preoperative patients and those who do not.
- Conditions
- Frail Elderly Syndrome, Muscle Weakness
- Being tested
- CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)Diagnostic test
GERIATRIC ASSESMENT TEST
| Study group | Role | What they receive |
|---|---|---|
| HIGH RISK | HIGH RISK MEANS PATIENTS HAVE ASA SCORE OVER 2 Receives: Diagnostic Test: CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX) | |
| LOW RISK | LOW RISK MEANS PATIENTS HAVE ASA SCORE BELOW 3 Receives: Diagnostic Test: CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DEATH RATE
PROPORTION OF PATIENTS WHO DIED TO ALL PATIENTS
Measured: AT 1 MONTH AND 3 MONTH AFTER OPERATION
LENGTH OF HOSPITAL STAY
NUMBER OF NIGHTS THE PATIENT NEEDS TO STAY IN HOSPITAL
Measured: AT 1 MONTH
DELIRIUM RATE
THE RATIO OF THE NUMBER OF PATIENTS IN DELIRIUM TO THE TOTAL NUMBER OF PATIENTS AFTER OPERATION
Measured: AT 1 MONTH
INTENSIVE CARE RATE
THE RATIO OF THE NUMBER OF PATIENTS NEED INTENSIVE CARE AFTER OPERATION TO TOTAL NUMBER OF PATIENTS
Measured: AT 1 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start17 Aug 2021
- Primary completion17 Oct 2022 (estimated)
- Study completion17 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sultan Keskin Demircan, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078983
- Sponsor's protocol ID
- 2021/11
- Status last verified
- Aug 2022
- First submitted
- 22 Sep 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Relation With Preoperative Fragility and ASA Score in Elderly Patients
- ClinicalTrials.gov ID
- NCT05078983
- Acronym / sponsor ID
- 2021/11
- Conditions
- Frail Elderly Syndrome, Muscle Weakness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 17 Oct 2022 (estimated)
- Study completion
- 17 Nov 2022 (estimated)
- First posted
- 15 Oct 2021 (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.
Frailty is a term specific to the geriatric period. It is used to describe weak, unstable, frail patients and partially expresses the frailty of the elderly patient. Once the frailty process begins, the risk of loss of mobility, dependency and mortality increases.
Frailty is an important predictor of adverse outcomes after surgery. According to studies conducted in various surgical situations, fragility is a major risk factor for morbidity, mortality and longer hospital stay. According to the available data, frailty has a sufficient basis for determining the risks of patients before surgery, developing preventive methods and making personal treatment decisions. As the frailty index increased, it was observed that the duration of postoperative hospital stay was associated with the need for intensive care, postoperative complications, and the rate of re-admissions within 30 days.
ASA (American Society of Anesthesiologists) classification is widely used in order to evaluate the physical condition preoperatively in geriatric individuals with multiple comorbidities. Considering the fragility variable while creating the ASA score in the preoperative period may be useful in determining the follow-up strategy during the operation and postoperative period. For example, a patient who is evaluated as ASA 2 because he has no problems other than simple 1-2 comorbid conditions, involuntary weakening of 5% in the last 1 year (not easily noticed), weakness (can only be detected with a dynamometer) and cessation of going out of the house (can only be understood when asked privately). ) can be categorized as at risk at ASA level 3-4, as it is understood to be fragile.
The aim of this project is to examine the frequency of frailty in elderly individuals who will be operated on, and to examine the relationship between frailty and ASA score using the anthropometry and comorbidity differences between frail preoperative patients and those who do not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIGH RISK | – | Diagnostic Test: CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)HIGH RISK MEANS PATIENTS HAVE ASA SCORE OVER 2 |
| LOW RISK | – | Diagnostic Test: CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)LOW RISK MEANS PATIENTS HAVE ASA SCORE BELOW 3 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients over the age of 65 who were admitted to the general surgery service for surgery and then operated.
Key inclusion criteria (1 listed)
- Patients over the age of 65 who were admitted to the general surgery service for surgery and then operated.
Key exclusion criteria (1 listed)
- -Patients with advanced stage dementia
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 |
|---|---|---|
| CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)GERIATRIC ASSESMENT TEST | Diagnostic test | HIGH RISK, LOW RISK |
Primary outcome
DEATH RATE
Time frame: AT 1 MONTH AND 3 MONTH AFTER OPERATION
PROPORTION OF PATIENTS WHO DIED TO ALL PATIENTS
LENGTH OF HOSPITAL STAY
Time frame: AT 1 MONTH
NUMBER OF NIGHTS THE PATIENT NEEDS TO STAY IN HOSPITAL
DELIRIUM RATE
Time frame: AT 1 MONTH
THE RATIO OF THE NUMBER OF PATIENTS IN DELIRIUM TO THE TOTAL NUMBER OF PATIENTS AFTER OPERATION
INTENSIVE CARE RATE
Time frame: AT 1 MONTH
THE RATIO OF THE NUMBER OF PATIENTS NEED INTENSIVE CARE AFTER OPERATION TO TOTAL NUMBER OF PATIENTS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Frail Elderly Syndrome and Muscle Weakness, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 4 Aug 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DEATH RATE (time frame: AT 1 MONTH AND 3 MONTH AFTER OPERATION). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2022.