Physical and Cognitive Effects of Fluoroscopy

NCT ID: NCT04689373

Last Updated: 2022-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background and objectives:

The researchers will perform this study to reveal the clinical meaning of fatigue, headache, diarrhea, and impaired cognitive functions that are often expressed verbally in healthcare professionals who are exposed to fluoroscopy.

Methods:

After obtaining written informed consent, 84 samples will be included in the study. For operating room employees who meet the criteria determined before and after the operation; mini-mental state examination, weight, heart rate, non-invasive blood pressure value, VAS score for headache, radiation exposure time on fluoroscopy device, Rad measurement with the help of personal dosimeter before and after surgery, and total time in the operating room will be recorded.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background and objectives:

Nowadays, operations under fluoroscopy are performed at increasing rates with the aim of increasing case management and surgical success. Due to this increasing exposure to radiation, it is important to show that fluoroscopy has an impact on employees not only annually but also daily. The researchers will perform this study to reveal the clinical meaning of fatigue, headache, diarrhea, and impaired cognitive functions that are often expressed verbally in healthcare workers who are exposed to fluoroscopy.

Methods:

After obtaining written informed consent; 84 samples consisting of orthopedic surgery and anesthesia residents and orthopedic operating room nurses between the ages of 18-60 who do not have cardiological, neurological and psychiatric diseases, have had fluoroscopic operations lasting more than 2 hours, wear protective scopy gowns and collar during surgery, will be included in the study. The total number of samples required for the study will be reached by taking repeated measurements on consecutive days from the same sample group, but not on the same day. For operating room employees who meet the criteria determined before and after the operation; mini-mental state examination, weight, heart rate, non-invasive blood pressure value, VAS score for headache, radiation exposure time on fluoroscopy device, Rad measurement with the help of personal dosimeter before and after surgery, and total time in the operating room will be recorded. This prospective study will be executed between December 2020 and June 2021.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dehydration Radiation Exposure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VAS Score

The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.

The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mini Mental State Examination

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Volunteering to participate in the study
2. ASA classification 1 or 2
3. Not leaving the operating room during the operation
4. To be carrying a fluoroscopy gown, protective collar, and dosimeter.

Exclusion Criteria

1. Having a psychiatric illness
2. Having a neurological disease
3. Being under the age of 18
4. Presence of cardiac pathology
5. Being pregnant or suspected of pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nur Canbolat

Principal Investigator, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nur Canbolat, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Faculty of Medicine Department of Anesthesiology

Elif Aygün, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Faculty of Medicine Department of Anesthesiology

Cansu Uzunturk, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Faculty of Medicine Department of Anesthesiology

Evren Aygun, MD

Role: STUDY_DIRECTOR

Istanbul University Faculty of Medicine Department of Anesthesiology

Yavuz Saglam, MD

Role: STUDY_CHAIR

Istanbul University Faculty of Medicine Department of Orthopedics

Mehmet I Buget, Assoc. Prof.

Role: STUDY_CHAIR

Istanbul University Faculty of Medicine Department of Anesthesiology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University, Faculty of Medicine

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Mohsen S, Elham H, Hassan V, Sajad B, Mohammad G, Razieh R (2016) Hematological findings in medical professionals involved at intraoperative fluoroscopy. Glob J Health Sci 8:12

Reference Type BACKGROUND

Sailer AM, Vergoossen L, Paulis L, van Zwam WH, Das M, Wildberger JE, Jeukens CRLPN. Personalized Feedback on Staff Dose in Fluoroscopy-Guided Interventions: A New Era in Radiation Dose Monitoring. Cardiovasc Intervent Radiol. 2017 Nov;40(11):1756-1762. doi: 10.1007/s00270-017-1690-5. Epub 2017 May 12.

Reference Type BACKGROUND
PMID: 28500459 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020/1424

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.