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Physical and Cognitive Effects of Fluoroscopy

Physical and Cognitive Effects of Fluoroscopy on Medical Professionals in the Operating Room : A Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04689373
Enrollment
84
Registered
2020-12-30
Start date
2021-06-30
Completion date
2022-01-31
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration, Radiation Exposure

Keywords

medical professionals, intraoperative fluoroscopy, low dose radiation

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTVAS 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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Heart RateIn the perioperative periodPulse oximeter
Non Invasive Blood PressureIn the perioperative periodSyphgmomanometer
WeightIn the perioperative periodWeighing machine

Secondary

MeasureTime frameDescription
Rad Measurement5 minutes after surgeryPersonal Dosimeter
Diarrhea2 hours after surgeryVerbal answers
Mini Mental State Examination15 minutes after surgeryMini Mental State Examination Scale (This scale is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.)
Total Time in the Operating RoomDuring surgeryChronometer
Visual Analog Scale (VAS) Score15 minutes after surgeryVAS Score Scale (Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain(0 mm) and worst pain(100mm).)
Radiation Exposure Time on Fluoroscopy DeviceDuring surgeryChronometer

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026