NCT03118102

Brief Summary

The investigators aim to investigate the effect of operating room noise on anesthetist hearing

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

April 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2018

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

April 9, 2017

Last Update Submit

January 8, 2018

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Extended high frequency audiometry

    pure tone audiometry in the frequency range from 250Hz-20,000Hz

    20 minutes

Secondary Outcomes (1)

  • Transient Evoked Otoacoustic Emission

    10 minutes

Study Arms (2)

anesthetist group

anesthetist doctor who subjected to noise in operating rooms

control group

doctors in the same hospital who are not subjected to noise in operating rooms

Eligibility Criteria

Age28 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

anesthetist doctor who subject to noise in operating rooms

You may qualify if:

  • anesthetist doctor and non-anesthetist doctor less than 40 years

You may not qualify if:

  • doctors above 40 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Khaled Salah Mohamed, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia and ICU

Study Record Dates

First Submitted

April 9, 2017

First Posted

April 18, 2017

Study Start

April 10, 2017

Primary Completion

January 8, 2018

Study Completion

January 8, 2018

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

EG(1)