UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040269
Receipt No. R000045939
Scientific Title Comparison of laryngoscopes under the aerosol box for tracheal intubation: a randomized crossover mannequin study
Date of disclosure of the study information 2020/04/30
Last modified on 2021/07/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of laryngoscopes under the aerosol box for tracheal intubation: a randomized crossover mannequin study
Acronym Comparison of laryngoscopes under the aerosol box for tracheal intubation: a randomized crossover mannequin study
Scientific Title Comparison of laryngoscopes under the aerosol box for tracheal intubation: a randomized crossover mannequin study
Scientific Title:Acronym Comparison of laryngoscopes under the aerosol box for tracheal intubation: a randomized crossover mannequinnstudy
Region
Japan

Condition
Condition mannequin
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the time taken for tracheal intubation under the aerosol box for tracheal intubation using three laryngoscopes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time taken for tracheal intubation
Key secondary outcomes Success rate of tracheal intubation, subjective difficulty score, incidence of esophageal intubation, Cormack-Lehane score

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 NO
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Macintosh direct laryngoscope
Interventions/Control_2 i-view video laryngoscope
Interventions/Control_3 C-MAC video laryngoscope
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Anesthesiologists with at least 2 years of experience in airway management
Key exclusion criteria Those who did not get consent
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Toshiyuki
Middle name
Last name Nakanishi
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code 467-8601
Address Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi prefecture
TEL +81-52-853-8281
Email nakanishi.anest@gmail.com

Public contact
Name of contact person
1st name Toshiyuki
Middle name
Last name Nakanishi
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code 467-8601
Address Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi prefecture
TEL +81-52-853-8281
Homepage URL
Email nakanishi.anest@gmail.com

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences, Department of Anesthesiology and Intensive Care Medicine
Institute
Department

Funding Source
Organization Nagoya City University Graduate School of Medical Sciences, Department of Anesthesiology and Intensive Care Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagoya City University Hospital, Clinical Research Management Center
Address Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi prefecture
Tel +81-52-851-5511
Email clinical_research@med.nagoya-cu.ac.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

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 30 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8234758/
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8234758/
Number of participants that the trial has enrolled 37
Results There was no significant difference in the intubation time: 30 [26-32] s for Macintosh, 29 [26-32] s for i-view, and 29 [25-31] s for C-MAC (P=0.247). The success rate was 95-100%, without a significant difference (P=0.135). The i-view and C-MAC exhibited superior Cormack-Lehane grades and lower subjective difficulty scale scores than the Macintosh; however, there were no differences between the i-view and C-MAC.
Results date posted
2021 Year 07 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 06 Month 26 Day
Baseline Characteristics We recruited 37 medical personnel with > 2 years of dedicated anesthesia experience from five hospitals.
Participant flow We enrolled 37 personnel; all their records were incorporated into the final analysis.
Adverse events None.
Outcome measures The primary outcome was the
intubation time. The secondary outcome included the success rate, Cormack-Lehane grade, and subjective difficulty scale score.
Plan to share IPD We will share individual deidentified participant data immediately following publication.
IPD sharing Plan description We will share individual deidentified participant data including outcome of the study (intubation time, whether success or failure, Cormack-Lehane grade, and numeric rating scale of subjective difficulty scale).
We will share data immediately after publication, with no set end date.
We will provide access to data for any purpose when a researcher makes a reasonable request for data.

Progress
Recruitment status Completed
Date of protocol fixation
2020 Year 04 Month 30 Day
Date of IRB
2020 Year 04 Month 30 Day
Anticipated trial start date
2020 Year 04 Month 30 Day
Last follow-up date
2020 Year 05 Month 11 Day
Date of closure to data entry
2020 Year 05 Month 11 Day
Date trial data considered complete
2020 Year 05 Month 11 Day
Date analysis concluded
2020 Year 05 Month 11 Day

Other
Other related information

Management information
Registered date
2020 Year 04 Month 29 Day
Last modified on
2021 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045939

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.