- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04673006
Risk of Bacterial Exposure to the Anesthesiologist's Face During Intubation and Extubation
October 14, 2021 updated by: Yonsei University
The practice of intubation and extubation is not without risks to the anesthesiologists.
Especially, the face of health care worker is the body part most commonly contaminated by splashes and sprays of body fluids.
The aim of this study is to determine the incidence of unrecognized exposure to the anesthesiologists' face during endotracheal intubation and extubation.
We will perform face shield swab before and after the endotracheal intubation and extubation.
All swabs will be cultured for 48 hours and the number of colony forming units before and after the procedures (intubation/extubation) will be compared.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All anesthesiologists who perform endotracheal intubation and extubation will be included in this study.
This study will be done only in patients who are scheduled for endotracheal intubation for elective surgeries.
Description
Inclusion Criteria:
- anesthesiologists who perform endotracheal intubation and extubation for patients scheduled for endotracheal intubation for elective surgeries
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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anesthesiologists who will perform endotracheal intubation and extubation for general anesthesia
All anesthesiologists in this study will use face shield for facial protection.
Face shield swab will be done before and after the procedures (intubation and extubation)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bacterial growth of face shield swab after the endotracheal extubation
Time Frame: Bacterial swab will be performed 5 minutes after the endotracheal extubation (after the confirmation of sufficient spontaneous breathing)
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All swab will be cultured for 48 hours and will be reported as no growth or by number of colony forming unit(CFU)s.
The number of CFU of post-extubation swab will be compared with that of pre-extubation swab.
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Bacterial swab will be performed 5 minutes after the endotracheal extubation (after the confirmation of sufficient spontaneous breathing)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bacterial growth of face shield swab after the endotracheal intubation
Time Frame: Bacterial swab will be performed 5 minutes after the endotracheal extubation (after the confirmation of adequate mechanical ventilation)
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All swab will be cultured for 48 hours and will be reported as no growth or by number of colony forming unit(CFU)s.
The number of CFU of post-intubation swab will be compared with that of pre-intubation swab.
|
Bacterial swab will be performed 5 minutes after the endotracheal extubation (after the confirmation of adequate mechanical ventilation)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seung Hyun Kim, Severance Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2021
Primary Completion (Actual)
June 28, 2021
Study Completion (Actual)
June 28, 2021
Study Registration Dates
First Submitted
December 11, 2020
First Submitted That Met QC Criteria
December 11, 2020
First Posted (Actual)
December 17, 2020
Study Record Updates
Last Update Posted (Actual)
October 15, 2021
Last Update Submitted That Met QC Criteria
October 14, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 4-2020-0529
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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