DehydrationNCT04689373
Physical and Cognitive Effects of Fluoroscopy
An observational study of Dehydration and Radiation Exposure, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Radiation Exposure
- What is being tested?
- VAS Score
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2021to 31 Jan 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
Who cannot join
- Having a psychiatric illness
- Having a neurological disease
- Being under the age of 18
- Presence of cardiac pathology
- Being pregnant or suspected of pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Faculty of Medicine
Istanbul, Fatih, 34093
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Dehydration, Radiation Exposure
- Being tested
- VAS Score
- Keywords
- medical professionals, intraoperative fluoroscopy, low dose radiation
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAS ScoreDiagnostic test
Also called Mini Mental State Examination
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Pulse oximeter
Measured: In the perioperative period
Non Invasive Blood Pressure
Syphgmomanometer
Measured: In the perioperative period
Weight
Weighing machine
Measured: In the perioperative period
Secondary outcomes (6)
Diarrhea
Verbal answers
Measured: 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)".)
Measured: 15 minutes after surgery
Radiation Exposure Time on Fluoroscopy Device
Chronometer
Measured: During surgery
Rad Measurement
Personal Dosimeter
Measured: 5 minutes after surgery
Total Time in the Operating Room
Chronometer
Measured: 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.)
Measured: 15 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start30 Jun 2021
- Primary completion21 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Canbolat, Istanbul University
- Investigators
- Nur Canbolat, MD, Principal investigator, Istanbul University Faculty of Medicine Department of AnesthesiologyElif Aygün, MD, Principal investigator, Istanbul University Faculty of Medicine Department of AnesthesiologyCansu Uzunturk, MD, Principal investigator, Istanbul University Faculty of Medicine Department of AnesthesiologyEvren Aygun, MD, Study director, Istanbul University Faculty of Medicine Department of AnesthesiologyYavuz Saglam, MD, Study chair, Istanbul University Faculty of Medicine Department of OrthopedicsMehmet I Buget, Assoc. Prof., Study chair, Istanbul University Faculty of Medicine Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689373
- Sponsor's protocol ID
- 2020/1424
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28500459
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Cognitive Effects of Fluoroscopy on Medical Professionals in the Operating Room : A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04689373
- Acronym / sponsor ID
- 2020/1424
- Conditions
- Dehydration, Radiation Exposure
- Keywords
- medical professionals, intraoperative fluoroscopy, low dose radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Having a psychiatric illness
- Having a neurological disease
- Being under the age of 18
- Presence of cardiac pathology
- Being pregnant or suspected of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAS ScoreAlso: Mini Mental State ExaminationThe 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. | Diagnostic test | – |
Primary outcome
Heart Rate
Time frame: In the perioperative period
Pulse oximeter
Non Invasive Blood Pressure
Time frame: In the perioperative period
Syphgmomanometer
Weight
Time frame: In the perioperative period
Weighing machine
6 secondary outcomes
Diarrhea
Time frame: 2 hours after surgery
Visual Analog Scale (VAS) Score
Time frame: 15 minutes after surgery
Radiation Exposure Time on Fluoroscopy Device
Time frame: During surgery
Rad Measurement
Time frame: 5 minutes after surgery
Total Time in the Operating Room
Time frame: During surgery
Mini Mental State Examination
Time frame: 15 minutes after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- BackgroundMohsen 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: PubMed 28500459Sailer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Canbolat, MD principal investigator
Istanbul University Faculty of Medicine Department of Anesthesiology
Elif Aygün, MD principal investigator
Istanbul University Faculty of Medicine Department of Anesthesiology
Cansu Uzunturk, MD principal investigator
Istanbul University Faculty of Medicine Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration and Radiation Exposure, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: In the perioperative period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04689373, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.