UMIN-CTR Clinical Trial

Basic information
Public title	Hemodynamic responses compared with videolaryngoscope and the Macintosh laryngoscope; A meta-analysis randomized control trials
Acronym	Hemodynamic responses compared with videolaryngoscope and the Macintosh laryngoscope
Scientific Title	Hemodynamic responses compared with videolaryngoscope and the Macintosh laryngoscope; A meta-analysis randomized control trials
Scientific Title:Acronym	Hemodynamic responses compared with videolaryngoscope and the Macintosh laryngoscope
Region	Japan

Condition
Condition	Patients with surgery under general anethsesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we performed meta-analysis comparing hemodynamic responses with the oral and nasal tracheal intubation using a videolaryngoscope and the Macintosh laryngoscope during general anesthesia so as to determine whether videolaryngoscope attenuated the hemodynamic responses.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood pressure and Heart rate
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion criteria for analysis required that each study be a prospective randomised trial or a comparison between the videolaryngoscope and the Macintosh laryngoscope in regard to the hemodynamic changes (heart rate;HRand mean blood pressure;MBP) under which oral and nasal tracheal intubation was performed in adult patients.
Key exclusion criteria	Article other than those included criteria
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Hoshijima
Organization	Saitama Medical University Hospital
Division name	Department of Anesthesiology
Zip code	350-0495
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
TEL	049-276-1271
Email	hhoshi@saitama-med.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Hoshijima
Organization	Saitama Medical University Hospital
Division name	Department of Anesthesiology
Zip code	350-0495
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
TEL	049-276-1271
Homepage URL
Email	hhoshi@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University Hospital
Institute
Department

Funding Source
Organization	Saitama Medical University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Teikyo University School of Medicine, International University of Health and Welfare,Yokohama City University Graduate School of Medicine, Allegheny Health Network, Tohoku university
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama Medical University Hospital
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
Tel	049-276-1271
Email	hhoshi@saitama-med.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	2016 Year 06 Month 01 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	2015 Year 01 Month 08 Day
Date of IRB	2015 Year 01 Month 08 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2016 Year 05 Month 04 Day
Last modified on	2019 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025573