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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038733
Receipt No. R000044006
Scientific Title The Effect of Nasal Canula prior to Tracheal Intubation on Preventing Hypoxemia in Neonate and Infant : a Double-blind,Ranrandomised Controlled Trial
Date of disclosure of the study information 2019/12/02
Last modified on 2019/11/29

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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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 02 Day
Last follow-up date
2020 Year 07 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
2019 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
Registered date File name


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