臨床研究等提出・公開システム

Date of registration	May. 22, 2025
Last modified on	May. 22, 2025
Trial ID	jRCT1040250033

Scientific Title	Association between first tracheal intubation success and video laryngoscope use in neonates: Multi-center retrospective cross-sectional study from J-PEDIA registry
Public Title	Association between first tracheal intubation success and video laryngoscope use in neonates: Multi-center retrospective cross-sectional study from J-PEDIA registry

Contact for Scientific Queries	Name	Kojima Taiki
	Affiliation	Aichi Children's Health and Medical Center
	Address	7-426, Moriokatyou, Obu Shi, Aichi Ken, 474-8710, Japan
	Telephone	+81-562-43-0500
	E-mail	nql41544@gmail.com
Contact for Public Queries	Name	Ukiya Tomoharu
	Affiliation	Chiba University Graduate School of Medicine
	Address	1-8-1, Inohana, Chiba Shi Chuo Ku, Chiba Ken, 260-8677, Japan
	Telephone	+81-43-222-7171
	E-mail	tomoharu.ukiya.915@gmail.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		May. 22, 2025
Target sample size		377
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	factorial assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	This study includes neonates of any gestational age who underwent tracheal intubation (oral or nasal) under general anesthesia, as recorded in the J-PEDIA registry.
	Exclusion Criteria	The J-PEDIA registry excludes the following cases: (1) emergency airway management performed outside the operating rooms, where anesthesiologists were consulted for resuscitation; (2) airway management procedures conducted in the emergency department or intensive care unit; and (3) duplicate cases recorded during the study period.
	Age Minimum	No limit
	Age Maximum	0age 0month 4week old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pediatric Anesthesia
Health Condition(s) Code		E03.155.422
Primary Outcome(s)		The primary outcome will be the first-attempt tracheal intubation (TI) succes in each encounter. The successful TI was pre-determined in the protocol as the stable hemodynamical and respiratory status is achieved after the completion of the tracheal tube placement.
Secondary Outcome(s)		The secondary outcomes include any adverse events (AEs), respiratory AEs, desaturation (a drop of SpO2 >10%), and POGO score in each encounter.

Primary Sponsor	none

Name of Certified Review Board	The institutional review board at Aichi Children's Health and Medical Center
Address	7-426, Moriokatyou, Obu Shi, Aichi Ken, 474-8710, Japan, Aichi
Telephone	+81-562-43-0500
Approval Status	Approval
Date of approval	Feb. 14, 2025

Countries of Recruitment（Except Japan）	none