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 UMIN000014636
Receipt No. R000016985
Scientific Title Video laryngoscopy versus direct laryngoscopy for double-lumen endotracheal tube intubation A prospective randomized study
Date of disclosure of the study information 2014/07/24
Last modified on 2014/11/13

* 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 Video laryngoscopy versus direct laryngoscopy for double-lumen endotracheal tube intubation A prospective randomized study
Acronym Video laryngoscopy versus direct laryngoscopy for double-lumen endotracheal tube intubation
Scientific Title Video laryngoscopy versus direct laryngoscopy for double-lumen endotracheal tube intubation A prospective randomized study
Scientific Title:Acronym Video laryngoscopy versus direct laryngoscopy for double-lumen endotracheal tube intubation
Region
Japan

Condition
Condition Patients who underwent general anesthesia
Classification by specialty
Chest surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comparison of direct and indirec laryngoscope for tracheal intubaiton
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Success rate and intubaiton time for tracheal intubation
Key secondary outcomes Subjective difficulty of laryngoscopy and tube passage through the glottis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intubation by direct laryngscope
Interventions/Control_2 Intubation by indirect laryngscope
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who underwent general anesthesia
Key exclusion criteria Patients with anticipated difficult airway
Target sample size 70

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Nobuyasu KOMASAWA
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka
TEL 072-683-1221
Email ane078@poh.osaka-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Nobuyasu Komasawa
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka
TEL 072-683-1221
Homepage URL
Email ane078@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
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
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
2014 Year 07 Month 24 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
McGrath was effective than McL for tracheal intubation of double lumen tube.
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
2014 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 21 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 04 Month 15 Day
Date analysis concluded
2015 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 24 Day
Last modified on
2014 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016985

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.