UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the Pentax-AWS Airway Scope and Airway Exchange Catheter for tracheal tube exchange in infants -A manikin study-
Title of the study (Brief title)	Utility of the Airway Scope for tracheal tube exchange
Region	Japan

Condition
Condition	Mechanical ventilation
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prove the utility of Airway Scope usage for tracheal tube exchange
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To determine whether tracheal tube exchange time using the Airway Scope is shorter than that using the Airway Exchange Catheter
Key secondary outcomes	To determine whether the Airway Scope reduced non-ventilation time compared with the Airway Exchange Catheter technique

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Anesthesiologists in our hospital
Key exclusion criteria	None
Target sample size	20

Research contact person
Name of lead principal investigator	Akihito Tampo
Organization	Asahikawa Medical University
Division name	Department of Emergency Medicine
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido
TEL	0166-68-2852
Email	atampo1031@gmail.com

Public contact
Name of contact person	Akihito Tampo
Organization	Asahikawa Medical University
Division name	Department of Emergency Medicine
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido
TEL	0166-68-2852
Homepage URL
Email	atampo1031@gmail.com

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2016 Year 08 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 01 Day
Anticipated trial start date	2012 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The time taken to visualize the vocal cords and the time taken to perform tracheal tube exchange were both shorter with the Airway Scope than with the Airway Exchange Catheter. In addition, non-ventilation time during tube exchange was significantly shorter with the Airway Scope.

Management information
Registered date	2016 Year 08 Month 18 Day
Last modified on	2016 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027264