Oxidative Stress in OR Personnel
Oxidative Stress Status During Anesthesia in Pediatric Surgical Room Staff Versus Non-operating Room Personnel: Pilot Study
1 other identifier
observational
N/A
1 country
1
Brief Summary
The purpose of this study is investigate to the effect(s) of chronic occupational exposure to N20 and volatile anesthetics on the extent of oxidative stress (DNA damage and the generation of the biochemical markers) in operating room staff, with different levels of exposure to halogenated hydrocarbons, in comparison to unexposed controls (Intensive Care Staff), and to determine the relationship between the degree of oxidative stress and psychological stress, as assessed by validated psychometric measures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 11, 2016
CompletedFirst Posted
Study publicly available on registry
January 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJanuary 25, 2018
January 1, 2018
1.8 years
January 11, 2016
January 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Oxidative Stress
The extent of oxidative stress (DNA damage and the generation of the biochemical markers) in operating room staff with different levels of exposure to halogenated hydrocarbons, in comparison to unexposed controls.
During exposure to volatile anesthetics over the course of a week in the work-place
Secondary Outcomes (1)
Psychological Stress
During exposure to volatile anesthetics over the course of a week in the work-place
Study Arms (2)
Pediatric Operating Room (OR) Staff
OR Staff exposed to nitrous oxide, and other volatile anesthetics
Pediatric Intensive Care Unit (ICU) Staff
ICU Staff unexposed to any volatile anesthetics
Interventions
No intervention, but routine work-place exposure to volatile anesthetics
Eligibility Criteria
Twenty operating room staff and twenty intensive care unit staff (40 Total Participants)
You may qualify if:
- CHOR-Staff who work \> 40 hours per week in the operating rooms (Anesthesiologists, CRNA, Surgeons, Nurses)
- NOR- Intensive Care Unit Staff who work \> 40 hours per week in Intensive care unit (Physicians, Nurses, APN'S)
You may not qualify if:
- Staff with the following history will be excluded:
- Therapeutic exposure to radiation
- On chemotherapeutic agents
- History of General Anesthesia during the past two years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Biospecimen
Two 5 mL blood samples collected at the start of a work week and at the end of a work week.
Study Officials
- PRINCIPAL INVESTIGATOR
Haleh Saadat, MD
Nationwide Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Complementary and Alternative Medicine
Study Record Dates
First Submitted
January 11, 2016
First Posted
January 13, 2016
Study Start
May 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
January 25, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share