Oxidative StressNCT02654834
Oxidative Stress in OR Personnel
An observational study of Oxidative Stress, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Exposure to nitrous oxide or other volatile anesthetics
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Mar 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Twenty operating room staff and twenty intensive care unit staff (40 Total Participants)
Who may be able to join
- 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)
Who cannot join
- Staff with the following history will be excluded:
- Therapeutic exposure to radiation
- On chemotherapeutic agents
- History of General Anesthesia during the past two years
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Oxidative Stress Status During Anesthesia in Pediatric Surgical Room Staff Versus Non-operating Room Personnel: Pilot Study
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.
Read the detailed description
This is a single blinded randomized, controlled and prospective clinical trial comparing oxidative stress status in two groups.
Subjects in two groups will be matched for gender, age, smoking habit and employment duration and will be randomized into one of the two groups of:
- Pediatric OR Staff, and
- control (e.g; ICU staff)
Biomarkers of oxidative stress will be measured in two different time points in each subject, (Monday Morning and, Friday afternoon of that same week->40 hours in Operating room or Intensive Care Unit).
The relationship between oxidative stress and psychological stress will also be assessed by validated psychometric measures.
- Conditions
- Oxidative Stress
- Being tested
- Exposure to nitrous oxide or other volatile anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to nitrous oxide or other volatile anestheticsOther
No intervention, but routine work-place exposure to volatile anesthetics
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Operating Room (OR) Staff | OR Staff exposed to nitrous oxide, and other volatile anesthetics Receives: Other: Exposure to nitrous oxide or other volatile anesthetics | |
| Pediatric Intensive Care Unit (ICU) Staff | ICU Staff unexposed to any volatile anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During exposure to volatile anesthetics over the course of a week in the work-place
Secondary outcomes (1)
Psychological Stress
To determine the relationship between oxidative stress and psychological stress, as assessed by validated psychometric measures.
Measured: During exposure to volatile anesthetics over the course of a week in the work-place
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startMay 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haleh Saadat, Nationwide Children's Hospital
- Investigators
- Haleh Saadat, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654834
- Sponsor's protocol ID
- IRB14-00098
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress Status During Anesthesia in Pediatric Surgical Room Staff Versus Non-operating Room Personnel: Pilot Study
- ClinicalTrials.gov ID
- NCT02654834
- Acronym / sponsor ID
- IRB14-00098
- Conditions
- Oxidative Stress
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Jan 2016 (estimated)
- 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.
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.
Detailed description
This is a single blinded randomized, controlled and prospective clinical trial comparing oxidative stress status in two groups.
Subjects in two groups will be matched for gender, age, smoking habit and employment duration and will be randomized into one of the two groups of:
- Pediatric OR Staff, and
- control (e.g; ICU staff)
Biomarkers of oxidative stress will be measured in two different time points in each subject, (Monday Morning and, Friday afternoon of that same week->40 hours in Operating room or Intensive Care Unit).
The relationship between oxidative stress and psychological stress will also be assessed by validated psychometric measures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Operating Room (OR) Staff | – | Other: Exposure to nitrous oxide or other volatile anestheticsOR Staff exposed to nitrous oxide, and other volatile anesthetics |
| Pediatric Intensive Care Unit (ICU) Staff | – | –ICU Staff unexposed to any volatile anesthetics |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Twenty operating room staff and twenty intensive care unit staff (40 Total Participants)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- Therapeutic exposure to radiation
- On chemotherapeutic agents
- History of General Anesthesia during the past two years
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 |
|---|---|---|
| Exposure to nitrous oxide or other volatile anestheticsNo intervention, but routine work-place exposure to volatile anesthetics | Other | Pediatric Operating Room (OR) Staff |
Primary outcome
Oxidative Stress
Time frame: During exposure to volatile anesthetics over the course of a week in the work-place
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.
1 secondary outcome
Psychological Stress
Time frame: During exposure to volatile anesthetics over the course of a week in the work-place
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Haleh Saadat, MD principal investigator
Nationwide Children's Hospital
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 Oxidative Stress, run by Nationwide Children's Hospital at 1 site in United States.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 25 Jan 2018. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Oxidative Stress (time frame: During exposure to volatile anesthetics over the course of a week in the work-place). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2018; AzTrials last refreshed its copy on 3 Nov 2026.