FrailtyCACANCT05998746
Comparison of ASA and CFS in Anesthesiology
An observational study of Frailty, run by Osijek University Hospital at 1 site in Croatia.
Trial summary
In addition to the regular ASA classification, patients would also be assigned the Clinical frailty scale (CFS) during preoperative examinations in anesthesiology clinics. The aim is to compare the usefulness of ASA and CFS categorization for predicting perioperative and postoperative complications and length of… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- How many people
- 200 participants
- Where
- 1 siteCroatia
- Study dates
- 17 Jul 2023to 3 Jun 2024
- How long will I take part?
- 2 Months
- 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
- Healthy volunteers accepted
- Older adult
Study population: Study population is all elective patients of the Osijek University Hospital older then 65 years who were included during the preoperative examination.
Who may be able to join
- All elective patients older then 65 years
Who cannot join
- Earlier mental difficulties that affect everyday life, senile dementia is not exclusion criteria
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Centre Osijek
Osijek, 31000
Slavica Kvolik, Prof., +38598723925, skvolik@mefos.hr
About this study
Official title: Comparison of ASA and CFS in Predicting Peri- and Postoperative Outcomes in Elective Patients Older Than 65 Years
In addition to the regular ASA classification, patients would also be assigned the Clinical frailty scale (CFS) during preoperative examinations in anesthesiology clinics. The aim is to compare the usefulness of ASA and CFS categorization for predicting perioperative and postoperative complications and length of postoperative stay in elective surgeries.
Read the detailed description
CFS significantly correlates with complications in patients treated in emergency department. This study is expected to provide information on how CFS correlates with complications and length of stay in elective surgeries.
In addition to the regular ASA classification, patients would also be assigned the Clinical frailty scale (CFS) during preoperative examinations in anesthesiology clinics.
The respondents are all elective patients over 65 years of age who have not had previously recorded mental difficulties that interfere with their daily life. Patients suffering from senile dementia would not be excluded from this study.
After the treatment was completed, the medical history of each patient would be reviewed and statistically processed.
The aim is to compare the usefulness of ASA and CFS categorization for predicting perioperative and postoperative complications and length of postoperative stay in elective surgeries.
- Conditions
- Frailty
- Keywords
- American Society of Anesthesiologists physical status;, Clinical frailty, Elderly, Treatment outcome
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri- and postoperative complications
Peri- and postoperative complications depending on CFS and ASA
Measured: During 2 months after elective operation
Secondary outcomes (1)
Length of stay in hospital
Length of stay in hospital after elective operation depending on CFS and ASA
Measured: During 2 months after elective operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start17 Jul 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion3 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 200 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Slavica Kvolik, MD, Study chair, Osijek University Hospital; Medical Faculty Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998746
- Sponsor's protocol ID
- OS-UH23
- Acronym
- CACA
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ASA and CFS in Predicting Peri- and Postoperative Outcomes in Elective Patients Older Than 65 Years
- ClinicalTrials.gov ID
- NCT05998746
- Acronym / sponsor ID
- CACA / OS-UH23
- Conditions
- Frailty
- Keywords
- American Society of Anesthesiologists physical status;, Clinical frailty, Elderly, Treatment outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 3 Jun 2024 (estimated)
- First posted
- 21 Aug 2023 (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.
In addition to the regular ASA classification, patients would also be assigned the Clinical frailty scale (CFS) during preoperative examinations in anesthesiology clinics. The aim is to compare the usefulness of ASA and CFS categorization for predicting perioperative and postoperative complications and length of postoperative stay in elective surgeries.
Detailed description
CFS significantly correlates with complications in patients treated in emergency department. This study is expected to provide information on how CFS correlates with complications and length of stay in elective surgeries.
In addition to the regular ASA classification, patients would also be assigned the Clinical frailty scale (CFS) during preoperative examinations in anesthesiology clinics.
The respondents are all elective patients over 65 years of age who have not had previously recorded mental difficulties that interfere with their daily life. Patients suffering from senile dementia would not be excluded from this study.
After the treatment was completed, the medical history of each patient would be reviewed and statistically processed.
The aim is to compare the usefulness of ASA and CFS categorization for predicting perioperative and postoperative complications and length of postoperative stay in elective surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Study population is all elective patients of the Osijek University Hospital older then 65 years who were included during the preoperative examination.
Key inclusion criteria (1 listed)
- All elective patients older then 65 years
Key exclusion criteria (1 listed)
- Earlier mental difficulties that affect everyday life, senile dementia is not exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peri- and postoperative complications
Time frame: During 2 months after elective operation
Peri- and postoperative complications depending on CFS and ASA
1 secondary outcome
Length of stay in hospital
Time frame: During 2 months after elective operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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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.
Slavica Kvolik, MD study chair
Osijek University Hospital; Medical Faculty Osijek
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 Osijek University Hospital at 1 site in Croatia.
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 21 Aug 2023. 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 Croatia. 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 Josip Kajan, Student (+385 98 1309 408, jkajan@mefos.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri- and postoperative complications (time frame: During 2 months after elective operation). 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 21 Aug 2023.