UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038733
Receipt number R000044006
Scientific Title The Effect of Nasal Canula prior to Tracheal Intubation on Preventing Hypoxemia in Neonate and Infant : a Double-blind,Randomised Controlled Trial
Date of disclosure of the study information 2019/12/02
Last modified on 2022/02/17 00:43:52

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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,Randomised 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,Randomised 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 or person

Institute

Saitama Children's Medical Center

Institute

Department

Personal name



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

2022 Year 02 Month 17 Day



Link to view the page

Value
https://center6.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