Comparison of ASA and CFS in Anesthesiology | NCT05998746

Studies
Comparison of ASA and CFS in Anesthesiology

NCT05998746

Sponsor

Osijek University Hospital

Status

Unknown status

Last Update Posted

Aug 21, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Frailty

Interventions

Not provided

Countries

Croatia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2023Actual

Primary Completion Date

Apr 30, 2024Estimated

Completion Date

Jun 3, 2024Estimated

First Submitted Date

Aug 11, 2023

First Submission Date that Met QC Criteria

Aug 11, 2023

First Posted Date

Aug 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2023

Last Update Posted Date

Aug 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peri- and postoperative complications	Peri- and postoperative complications depending on CFS and ASA	During 2 months after elective operation

Secondary Outcomes

Measure	Description	Time Frame
Length of stay in hospital	Length of stay in hospital after elective operation depending on CFS and ASA	During 2 months after elective operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All elective patients older then 65 years

Exclusion Criteria:

Earlier mental difficulties that affect everyday life, senile dementia is not exclusion criteria

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Josip Kajan, Student	Contact	+385 98 1309 408		jkajan@mefos.hr
Slavica Kvolik, M.D. Ph.D.	Contact	098723925		slavica.kvolik@gmail.com

Overall Officials

Name	Affiliation	Role
Slavica Kvolik, MD	Osijek University Hospital; Medical Faculty Osijek	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Centre Osijek	Recruiting	Osijek		31000	Croatia

Condition Browse Module

MeSH Terms

ID	Term
D000073496	Frailty

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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