Physical and Cognitive Effects of Fluoroscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Dehydration; Radiation Exposure
• Intervention / Treatment: Diagnostic test: VAS Score

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 Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Istanbul University, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Pulse oximeter	In the perioperative period
Non Invasive Blood Pressure	Syphgmomanometer	In the perioperative period
Weight	Weighing machine	In the perioperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diarrhea	Verbal answers	2 hours after surgery
Visual Analog Scale (VAS) Score	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)".)	15 minutes after surgery
Radiation Exposure Time on Fluoroscopy Device	Chronometer	During surgery
Rad Measurement	Personal Dosimeter	5 minutes after surgery
Total Time in the Operating Room	Chronometer	During surgery
Mini Mental State Examination	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.)	15 minutes after surgery

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Nur Canbolat, MD, Istanbul University Faculty of Medicine Department of Anesthesiology; Principal Investigator: Elif Aygün, MD, Istanbul University Faculty of Medicine Department of Anesthesiology; Principal Investigator: Cansu Uzunturk, MD, Istanbul University Faculty of Medicine Department of Anesthesiology; Study Director: Evren Aygun, MD, Istanbul University Faculty of Medicine Department of Anesthesiology; Study Chair: Yavuz Saglam, MD, Istanbul University Faculty of Medicine Department of Orthopedics; Study Chair: Mehmet I Buget, Assoc. Prof., Istanbul University Faculty of Medicine Department of Anesthesiology

Publications and helpful links

General Publications

• 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
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): January 21, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 25, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: medical professionals; intraoperative fluoroscopy; low dose radiation
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: 2020/1424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No