Physical and Cognitive Effects of Fluoroscopy

NCT04689373 | Completed

• 1 other identifier: 2020/1424
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration; Radiation Exposure

Keywords

medical professionals; intraoperative fluoroscopy; low dose radiation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Diarrhea

  2 hours after surgery

• Visual Analog Scale (VAS) Score

  15 minutes after surgery

• Radiation Exposure Time on Fluoroscopy Device

  During surgery

• Rad Measurement

  5 minutes after surgery

• Total Time in the Operating Room

  During surgery

Interventions

VAS Score DIAGNOSTIC_TEST

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.

Also known as: Mini Mental State Examination

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Volunteering to participate in the study
• ASA classification 1 or 2
• Not leaving the operating room during the operation
• To be carrying a fluoroscopy gown, protective collar, and dosimeter.

You may not qualify if:

• Having a psychiatric illness
• Having a neurological disease
• Being under the age of 18
• Presence of cardiac pathology
• Being pregnant or suspected of pregnancy

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related 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

  BACKGROUND

• 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.

  PMID: 28500459 BACKGROUND

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Evren Aygun, MD

  Istanbul University Faculty of Medicine Department of Anesthesiology

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 30, 2020
• Study Start: June 30, 2021
• Primary Completion: January 21, 2022
• Study Completion: January 31, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

TU (1)