臨床研究等提出・公開システム

Scientific Title	Comparing oropharyngeal leak pressure between i-gel Plus and conventional i-gel: A randomized controlled study (OPLP i-gel Plus vs i-gel)
Public Title	Comparing oropharyngeal leak pressure between i-gel Plus and i-gel (OPLP i-gel Plus vs i-gel)

Contact for Scientific Queries	Name	Chaki Tomohiro
	Affiliation	Sapporo Medical University School of Medicine Hospital
	Address	291, South 1, West 16, Chuo-ku, Sapporo
	Telephone	+81-11-611-2111
	E-mail	chakitomohiro@sapmed.ac.jp
Contact for Public Queries	Name	Chaki Tomohiro
	Affiliation	Sapporo Medical University School of Medicine Hospital
	Address	291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
	Telephone	+81-11-611-2111
	E-mail	chakitomohiro@sapmed.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 27, 2023
Actual date of first enrollment
Target sample size		234
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who undergo surgery under general anesthesia
	Exclusion Criteria	Patients who underwent oral or pharyngeal surgery and radiotherapy Patients who is unsuitable for the airway management using suplaglottic airway device
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		General anesthesia
Intervention(s)		The airway management is performed using i-gel Plus or i-gel.
Health Condition(s) Keyword		General anesthesia
Intervention(s) Keyword		Supraglottic airway device
Health Condition(s) Code		D046650
Intervention(s) Code		D017214
Primary Outcome(s)		Oropharyngeal leak pressure
Secondary Outcome(s)		Successful insertion rate at first attempt Number of attempts for successful insertion of SGA Time required for successful insertion of SGA Ventilation score Maximum airway pressure and expiratory tidal volume at 10 mL/kg VCV Incidence of hoarceness, sore throat and blood stain on SGA

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Sapporo Medical University School of Medicine
Address	291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan, Hokkaido
Telephone	+81-11-611-2111
E-Mail	chakitomohiro@sapmed.ac.jp
Approval Status	Approval
Date of approval	Sept. 14, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	July. 30, 2025	(this page)	Changes
1	Sept. 27, 2023	Detail

List of change history