Clinical trial NCT04689373: Physical and Cognitive Effects of Fluoroscopy
Official title: Physical and Cognitive Effects of Fluoroscopy on Medical Professionals in the Operating Room : A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dehydration
Radiation Exposure
Keywords: medical professionals
intraoperative fluoroscopy
low dose radiation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate
timeFrame: In the perioperative period
measure: Non Invasive Blood Pressure
timeFrame: In the perioperative period
measure: Weight
timeFrame: In the perioperative period
Secondary outcomes:
measure: Diarrhea
timeFrame: 2 hours after surgery
measure: Visual Analog Scale (VAS) Score
timeFrame: 15 minutes after surgery
measure: Radiation Exposure Time on Fluoroscopy Device
timeFrame: During surgery
measure: Rad Measurement
timeFrame: 5 minutes after surgery
measure: Total Time in the Operating Room
timeFrame: During surgery
measure: Mini Mental State Examination
timeFrame: 15 minutes after surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Faculty of Medicine
state: Fatih
Study officials:
affiliation: Istanbul University Faculty of Medicine Department of Anesthesiology
name: Nur Canbolat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Faculty of Medicine Department of Anesthesiology
name: Elif Aygün, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Faculty of Medicine Department of Anesthesiology
name: Cansu Uzunturk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Faculty of Medicine Department of Anesthesiology
name: Evren Aygun, MD
role: STUDY_DIRECTOR
affiliation: Istanbul University Faculty of Medicine Department of Orthopedics
name: Yavuz Saglam, MD
role: STUDY_CHAIR
affiliation: Istanbul University Faculty of Medicine Department of Anesthesiology
name: Mehmet I Buget, Assoc. Prof.
role: STUDY_CHAIR
References:
citation: 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
citation: 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.