臨床研究等提出・公開システム

Date of registration	July. 30, 2021
Last modified on	May. 24, 2023
Trial ID	jRCT1032210212

Scientific Title	Examination of airway management methods to prevent COVID-19 infection by viral aerosols produced during cough reflex
Public Title	Examination of airway management methods to prevent COVID-19 infection by viral aerosols produced during cough reflex

Completion date	July. 31, 2021
Result actual enrolment	20
Baseline Characteristics	Volunteers (20 age years old above) with written informed consent.
Participant flow	An observational study was conducted with 20 volunteers.
Adverse events	None
Outcome measures	The amount of aerosols during coughing were measured, with and without the use of the air extractor, while the participant was coughing three times (of separate timings) in 30 seconds. Wilcoxon signed rank sum test was used to compare the aerosol counts with and without the air extractor. The aerosol count during coughing was significantly lower when the suction system was used (median: 55 (interquartile range: 15-128)) than when it was not used (73 (44-201)) (p = 0.001, difference: 19 (4-70)).
Brief summary	The aerosol count during coughing was significantly lower when the suction system was used (median: 55 (interquartile range: 15-128)) than when it was not used (73 (44-201)) (p = 0.001, difference: 19 (4-70)). The air extractor would reduce exposure of healthcare providers to infectious aerosols emitted by coughing, but a considerable amount of aerosols may still be exposed to healthcare providers.
Date of posting of results summaries	Nov. 30, 2022
Date of the first journal publication of results	Nov. 30, 2022

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1032210212

Contact for Scientific Queries	Name	Okuda Yasuhisa
	Affiliation	Dokkyo Medical University Saitama Medical Center, Department of Anesthesia
	Address	2-1-50,Minamikoshigaya,Koshigayashi,Saitama-ken,343-8555,Japan
	Telephone	+81-489651111
	E-mail	y-okuda@dokkyomed.ac.jp
Contact for Public Queries	Name	Fujishiro Asuka
	Affiliation	Dokkyo Medical University Saitama Medical Center, Department of Anesthesia
	Address	2-1-50,Minamikoshigaya,Koshigayashi,Saitama-ken,343-8555,Japan
	Telephone	+81-489651111
	E-mail	asuka-f@dokkyomed.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 28, 2021
Actual date of first enrollment		April. 28, 2021
Target sample size		20
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Volunteers (20 age years old above) with written informed consent.
	Exclusion Criteria	Cold symptoms. Infection signs. Respiratory disease. Patients with COVID-19 test positive or close contact with COVID-19.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		COVID-19
Primary Outcome(s)		Amount of aerosol produced during coughing

Primary Sponsor	Dokkyo Medical University Saitama Medical Center

Name of Certified Review Board	Bioethics Committee Saitama Medical Center Dokkyo Medical University
Address	2-1-50,Minamikoshigaya,Koshigayashi,343-8555,Japan, Saitama
Telephone	+81-48-965-1111
Approval Status	Approval
Date of approval	April. 21, 2021

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	May. 24, 2023	(this page)	Changes
1	July. 30, 2021	Detail

List of change history