NCT02654834

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

January 11, 2016

Last Update Submit

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

Other: Exposure to nitrous oxide or 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

Pediatric Operating Room (OR) Staff

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two 5 mL blood samples collected at the start of a work week and at the end of a work week.

Study Officials

  • Haleh Saadat, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR
0

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

Locations