UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020788 |
|---|---|
| Receipt number | 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 10:47:06 |
* 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 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 | Obstetrics 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
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
travis3939@nifty.com
Sponsor or person
Institute
Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023233
