臨床研究等提出・公開システム

Scientific Title	Comparison of oropharyngeal leak pressure between i-gel and LMA-Supreme in awake craniotomy: a randomized controlled trial
Public Title	Comparison of efficacy of supraglottic airway device in awake craniotomy

Contact for Scientific 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	chakitomohiro0728@yahoo.co.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	chakitomohiro0728@yahoo.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 12, 2021
Actual date of first enrollment		Mar. 15, 2021
Target sample size		70
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who undergo brain tumor resection or seizure focus resection under awake craniotomy
	Exclusion Criteria	Patients who are not suitable for airway management using suplaglottic airway device
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Brain tumor, Seizure
Intervention(s)		Airway management using i-gel or LMA-Supreme according to randomization
Health Condition(s) Keyword		brain tumor, epilepsy, awake craniotomy
Intervention(s) Keyword		suplaglottic airway device
Health Condition(s) Code		D001932, D004827
Intervention(s) Code
Primary Outcome(s)		oropharyngeal leak pressure
Secondary Outcome(s)		Ventilation score, maximum airway pressure and expiratory tidal volume at 10 mL/kg IBW positive pressure ventilation, observational findings of vocal folds, time to insert i-gel or LMA-Supreme, incidence of adverse event

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 Hospital
Address	291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido
Telephone	+81-11-611-2111
E-Mail	ji-rskk@sapmed.ac.jp
Approval Status	Approval
Date of approval	Mar. 11, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)	UMIN000043615
Issuing Authority	UMIN-CTR

Countries of Recruitment（Except Japan）	none