UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010740
Receipt number R000012551
Scientific Title Comparison of pediatric intubation device using cervical immobilized simulator during chest compression
Date of disclosure of the study information 2013/05/16
Last modified on 2013/05/16 12:40:32

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Basic information

Public title

Comparison of pediatric intubation device using cervical immobilized simulator during chest compression

Acronym

Comparison of pediatric intubation device using cervical immobilized simulator during chest compression

Scientific Title

Comparison of pediatric intubation device using cervical immobilized simulator during chest compression

Scientific Title:Acronym

Comparison of pediatric intubation device using cervical immobilized simulator during chest compression

Region

Japan


Condition

Condition

cardiac arrest due to trauma

Classification by specialty

Pediatrics Anesthesiology Emergency medicine
Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare time to intubation with video-laryngoscope, AirwayScope (AS) (Hoya, Tokyo, Japan) in a simulated trauma child with cervical spine immobilization during chest compression with that with conventional laryngoscope (CL) at 6 weeks after watching brief standardized instruction video for each.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

time to intubation 6 weeks after the interventions, in a simulated cardiac arrest child with cervical spine immobilization

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

standardized instruction video for AirwayScope

Interventions/Control_2

standardized instruction video for conventional laryngoscope

Interventions/Control_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


Not applicable

Gender

Male and Female

Key inclusion criteria

non-anesthesia physician at Tokyo Metropolitan Children's Medical Center

Key exclusion criteria

1. those who don't agree
2. those who will move to other hospitals within 6 weeks

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takanari Ikeyama

Organization

Tokyo Metropolitan Children's Medical Center, Japan

Division name

Department of Pediatric Emergency and Critical Care Medicine

Zip code


Address

2-8-29 Musashidai, Fuchu, Tokyo JAPAN zip 183-8561

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokyo Metropolitan Children's Medical Center, Japan

Division name

Department of Pediatric Emergency and Critical Care Medicine

Zip code


Address


TEL


Homepage URL

http://www.byouin.metro.tokyo.jp/shouni/tiken/koukaigenkou/24-48doctor.pdf

Email



Sponsor or person

Institute

Tokyo Metropolitan Children's Medical Center, Japan

Institute

Department

Personal name



Funding Source

Organization

Tokyo Metropolitan Children's Medical Center, Japan

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 16 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2012 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 01 Day

Last follow-up date

2013 Year 05 Month 02 Day

Date of closure to data entry

2013 Year 05 Month 02 Day

Date trial data considered complete

2013 Year 05 Month 10 Day

Date analysis concluded

2013 Year 05 Month 16 Day


Other

Other related information



Management information

Registered date

2013 Year 05 Month 16 Day

Last modified on

2013 Year 05 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012551


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name