The Effect of a Reduced Noise Environment on the Response Time of the Anesthesia Provider
1 other identifier
interventional
48
1 country
1
Brief Summary
This project will investigate whether reduction in ambient light and elimination of noise during induction and emergence from anesthesia influences the response time of the anesthesia provider to auditory and visual alarms when compared to a standard operating room. In addition, the investigators will assess the cumulative level of noise exposure that providers experience during the perioperative period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
April 16, 2018
CompletedFirst Posted
Study publicly available on registry
April 25, 2018
CompletedStudy Start
First participant enrolled
October 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedJanuary 8, 2024
January 1, 2024
3.1 years
April 16, 2018
January 4, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Induction response time
Response time of the anesthesia provider to the auditory/visual alarm during induction of anesthesia
Within 5 mins of patient entering the OR
Emergence response time
Response time of the anesthesia provider to the auditory/visual alarm during emergence from anesthesia
Within 5-15 mins after completion of surgery
Secondary Outcomes (1)
Noise exposure
Average of 30 mins - 3 hrs
Study Arms (2)
Noise reduction
EXPERIMENTALReduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia.
Control
ACTIVE COMPARATORNormal operating room environment.
Interventions
All activity will cease when the patient enters the operating room and nonessential personnel will be removed. Ambient lighting will be reduced and communication devices muted.
Eligibility Criteria
You may qualify if:
- Anesthesia providers that have agreed to participate.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joshua Uffmanlead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Related Publications (1)
Bozych M, Tram NK, Rice-Weimer J, Cartabuke RS, Tobias JD, Huffman J, Mpody C, Uffman JC. Operating Room Noise Environment and Behavior in Children Undergoing General Anesthesia: A Randomized Controlled Trial. Anesthesiol Res Pract. 2024 Aug 16;2024:4838649. doi: 10.1155/2024/4838649. eCollection 2024.
PMID: 39185368DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Cartabuke, MD
Nationwide Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice Chair, Department of Anesthesiology & Pain Medicine
Study Record Dates
First Submitted
April 16, 2018
First Posted
April 25, 2018
Study Start
October 18, 2018
Primary Completion
November 30, 2021
Study Completion
November 30, 2021
Last Updated
January 8, 2024
Record last verified: 2024-01