Physical and Cognitive Effects of Fluoroscopy

Completed

• Conditions: Dehydration; Radiation Exposure

• Registration Number: NCT04689373
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-25
• Study First Posted: 2020-12-30
• Study Start: 2021-06-30
• Status Verified: 2022-01
• Primary Completion: 2022-01-21
• Study Completion: 2022-01-31
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart Rate	In the perioperative period	Pulse oximeter
Non Invasive Blood Pressure	In the perioperative period	Syphgmomanometer
Weight	In the perioperative period	Weighing machine

Secondary Outcome Measures

Name	Time	Method
Rad Measurement	5 minutes after surgery	Personal Dosimeter
Diarrhea	2 hours after surgery	Verbal answers
Visual Analog Scale (VAS) Score	15 minutes after surgery	VAS 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 Device	During surgery	Chronometer
Total Time in the Operating Room	During surgery	Chronometer
Mini Mental State Examination	15 minutes after surgery	Mini 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.)

Trial Locations

Locations (1)

Istanbul University, Faculty of Medicine; 🇹🇷 Istanbul, Fatih, Turkey