UMIN-CTR Clinical Trial

Basic information
Public title	Detection of esophageal intubation with the Macintosh laryngoscope and the video laryngoscope: a standard and difficult manikin study
Acronym	Detection of esophageal intubation after intubation attempts with the Macintosh laryngoscope and the video laryngoscope: a standard and difficult manikin study
Scientific Title	Detection of esophageal intubation after intubation attempts with the Macintosh laryngoscope and the video laryngoscope: a standard and difficult manikin study
Scientific Title:Acronym	Detection of esophageal intubation with the Macintosh laryngoscope and the video laryngoscope
Region	Japan

Condition
Condition	a standard and difficult airway manikin
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy of the McGrath MAC video lar yngoscope and the Macintosh laryngoscope to distinguish between tracheal and esophageal placement of the tube in a standard and difficult airway manikin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	time for detection of the tube position
Key secondary outcomes	success rate of detection of true position, frequency of dental damage

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Macintosh laryngoscope
Interventions/Control_2	McGrath MAC video laryngoscope
Interventions/Control_3	a normal manikin
Interventions/Control_4	a difficult airway manikin
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	primary residents who had experienced more than 30 cases of tracheal intubation
Key exclusion criteria	without consent
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Kazuyoshi Middle name Last name Aoyama
Organization	Kitakyushu General Hospital
Division name	Department of Anesthesia
Zip code	802-8517
Address	1-1 Higashijono-machi, Kokurakit a-ku, Kitakyushu
TEL	093-921-0560
Email	kazuyoshi.aoyama@kitakyu-hp.or.jp

Public contact
Name of contact person	1st name Kazuyoshi Middle name Last name Aoyama
Organization	Kitakyushu General Hospital
Division name	Department of Anesthesia
Zip code	802-8517
Address	1-1 Higashijono-machi, Kokurakit a-ku, Kitakyushu
TEL	093-921-0560
Homepage URL
Email	kazuyoshi.aoyama@kitakyu-hp.or.jp

Sponsor
Institute	Department of Anesthesia, Kitakyushu General Hospital
Institute
Department

Funding Source
Organization	Department of Anesthesia, Kitakyushu General Hospital
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	Ethics committee of Kitakyushu General H ospital
Address	1-1 Higashijono-machi, Kokurakita- ku, Kitakyushu
Tel	093-921-0560
Email	yoshifumi.nakayama@kitakyu-hp.or.jp

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	北九州総合病院（福岡県）

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 26 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	Completed
Date of protocol fixation	2019 Year 11 Month 22 Day
Date of IRB	2019 Year 11 Month 15 Day
Anticipated trial start date	2019 Year 11 Month 23 Day
Last follow-up date	2020 Year 12 Month 01 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 25 Day
Last modified on	2021 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044064