UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Nasal Canula prior to Tracheal Intubation on Preventing Hypoxemia in Neonate and Infant : a Double-blind,Ranrandomised Controlled Trial
Acronym	Apneic Oxyganation by Nasal Canula in Neonate and Infant
Scientific Title	The Effect of Nasal Canula prior to Tracheal Intubation on Preventing Hypoxemia in Neonate and Infant : a Double-blind,Ranrandomised Controlled Trial
Scientific Title:Acronym	Apneic Oxyganation by Nasal Canula in Neonate and Infant
Region	Japan

Condition
Condition	Neonate and infant who require intubation under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of oxygen administration using a nasal cannula during intubation in neonate and infant.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Time from the start of intubation until SpO2 drops to 95%.
Key secondary outcomes	1)Time and SpO2 from the start of intubation to the end of the first or second intubation. Time and SpO2 until the re-mask ventilation. 2)SpO2 every 15 seconds from intubation start to completion. 3)Extract cases that required time for intubation and compare the lowest SpO2 by group. 4)Incidence of complications from oxygen administration from nasal cannula.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	After the induction of general anesthesia, we will attach an atom nasal cannula to all patients but administer oxygen to control group patients (group 1). We provide patient ventilation with 100% FiO2. After muscle relaxation, we stop mask ventilation to patients and start intubation.
Interventions/Control_2	We administer 0.2L/kg/min oxygen to patients in group 2.
Interventions/Control_3	We administer 1.0L/kg/min oxygen to patients in group 3.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	24 months-old >
Gender	Male and Female
Key inclusion criteria	1) Men and women who have general anesthesia at our hospital for 0 months or more and less than 24 months. 2) Patients with ASA-PS1 or 2. 3) When the patient's representative shows sufficient understanding and consents to participate.
Key exclusion criteria	Rapid sequence induction Emergency case Predicted difficult airways Differential lung ventilation Heart and cardiovascular disease Congenital heart disease and respiratory disease
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Sachi Middle name Last name Ishida
Organization	Saitama Children's Medical Center
Division name	Anesthesiology
Zip code	330-8777
Address	1-2 Shintoshin, Chuou-ku, Saitama, Japan
TEL	048-601-2200
Email	sishida-bb@umin.ac.jp

Public contact
Name of contact person	1st name Sachi Middle name Last name Ishida
Organization	Saitama Children's Medical Center
Division name	Anesthesiology
Zip code	330-8777
Address	1-2 Shintoshin, Chuou-ku, Saitama, Japan
TEL	048-601-2200
Homepage URL
Email	sishida-bb@umin.ac.jp

Sponsor
Institute	Saitama Children's Medical Center
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama Children's Medical Center Ethics Committee
Address	1-2 Shintoshin, Chuou-ku, Saitama, Japan
Tel	048-601-2200
Email	fujihira.tatsuhiko@pref.saitama.lg.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2019-04-001
Org. issuing International ID_1	Saitama Children's Medical Center Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 11 Month 14 Day
Date of IRB	2019 Year 11 Month 14 Day
Anticipated trial start date	2019 Year 12 Month 02 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 29 Day
Last modified on	2020 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044006

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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