Physical and Cognitive Effects of Fluoroscopy

Dehydration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689373
• Other study ID #: 2020/1424
• Status: Completed
• Start date: June 30, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 31, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Radiation Exposure

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University, Faculty of Medicine	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	Pulse oximeter	In the perioperative period
Primary	Non Invasive Blood Pressure	Syphgmomanometer	In the perioperative period
Primary	Weight	Weighing machine	In the perioperative period
Secondary	Diarrhea	Verbal answers	2 hours after surgery
Secondary	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
Secondary	Radiation Exposure Time on Fluoroscopy Device	Chronometer	During surgery
Secondary	Rad Measurement	Personal Dosimeter	5 minutes after surgery
Secondary	Total Time in the Operating Room	Chronometer	During surgery
Secondary	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