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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020788
Receipt No. R000023233
Scientific Title Comparison of hemodynamic responses to tracheal intubation between using the McGRATH Mac and Macintosh laryngoscope
Date of disclosure of the study information 2016/01/29
Last modified on 2016/01/29

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Basic information
Public title Comparison of hemodynamic responses to tracheal intubation between using the McGRATH Mac and Macintosh laryngoscope
Acronym Comparison of hemodynamic responses to tracheal intubation between using the McGRATH Mac and Macintosh laryngoscope
Scientific Title Comparison of hemodynamic responses to tracheal intubation between using the McGRATH Mac and Macintosh laryngoscope
Scientific Title:Acronym Comparison of hemodynamic responses to tracheal intubation between using the McGRATH Mac and Macintosh laryngoscope
Region
Japan

Condition
Condition patients scheduled for elective open or laparoscopic abdominal surgery which needs intubation and invasive arterial blood pressure monitoring
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Obsterics and gynecology
Urology Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the response to tracheal intubation between the McGRATH Mac and Macintosh laryngoscope by using invasive blood pressure monitoring.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Systolic blood pressure, diastolic blood pressure and heart rate will be recorded at the following ten time points: 1 ) before the induction of anesthesia, 2 )the time of train-of-four count was zero and the effect-site concentration of fentanyl is maximum level, 3 ) after keeping the laryngscopy for ten seconds, 4 ) immediately after intubation, and 5-9 ) 1, 2, 3, 4 and 5 minutes after intubation, 10 ) the maximum point of the systolic blood pressure
Key secondary outcomes

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 YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Group G (group of intubation by using McGRATH Mac): n=23
Interventions/Control_2 Group C (group of intubation by using Macintosh laryngoscope): n=23
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 scheduled for elective open or laparoscopic abdominal surgery under general anaesthesia requiring tracheal intubation and invasive blood pressure monitoring
Key exclusion criteria Patients were excluded if they were suspected to have either conditions or past medical histories below; 1) difficult airway 2) cardiac diseases 3) aortic diseases, 4) cerebrovascular diseases, 5) endocrine diseases with influence on hemodynamic responses 6) morbid obesity.
Target sample size 46

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Kimura
Organization The Jikei University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 163-1 Kashiwashita, Kashiwa City, Chiba, Japan
TEL +81-(0)4-7164-1111
Email travis3939@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Kimura
Organization The Jikei University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 163-1 Kashiwashita, Kashiwa City, Chiba, Japan
TEL +81-(0)4-7164-1111
Homepage URL
Email travis3939@nifty.com

Sponsor
Institute Department of Anesthesiology
Institute
Department

Funding Source
Organization Department of Anesthesiology
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
2016 Year 01 Month 29 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 Open public recruiting
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 29 Day
Last modified on
2016 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023233

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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