UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018779 |
|---|---|
| Receipt number | R000021724 |
| Scientific Title | Randomized controlled trial of hemodynamic change during intubation with McGRATH compared to Macintosh laryngoscope by inexperienced anesthetic residents. randomized control trial |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2017/08/25 12:58:12 |
* 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
Randomized controlled trial of hemodynamic change during intubation with McGRATH compared to Macintosh laryngoscope by inexperienced anesthetic residents.
randomized control trial
Acronym
Effect of hemodynamic change with intubation device.
Scientific Title
Randomized controlled trial of hemodynamic change during intubation with McGRATH compared to Macintosh laryngoscope by inexperienced anesthetic residents.
randomized control trial
Scientific Title:Acronym
Effect of hemodynamic change with intubation device.
Region
| Japan |
Condition
Condition
Patients who planed general anesthesia with 1 or 2 of american society of anesthesia physical status
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether McGRATH videolaryngoscope suppress hemodynamic change during intubation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamic change pre and post intubation
Key secondary outcomes
number of laryngoscopies, hoarseness, pharyngeal pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intubation with McGRATH videolaryngoscope
Interventions/Control_2
Intubation with Macintosh laryngoscope
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who planned general anesthesia with 1 or 2 of american society of anesthesiology physical status.
Key exclusion criteria
Patients who were not able to be intubated by anesthesia resident, were excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Terahata |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-9 Fukuura Kanazawaku Yokohama
TEL
+81457872918
shunty5323@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | shunsuke takaki |
Organization
Yokohama City University
Division name
Intensive Care Medicine
Zip code
Address
3-9 Fukuura Kanazawaku Yokohama
TEL
+814578782918
Homepage URL
shunty5323@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital 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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | 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
| 2015 | Year | 08 | Month | 24 | Day |
Last modified on
| 2017 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021724
