UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020450 |
|---|---|
| Receipt number | R000022672 |
| Scientific Title | Evaluation of cricoid pressure effect on tracheal intubation with McGRATH MAC |
| Date of disclosure of the study information | 2016/01/08 |
| Last modified on | 2016/02/22 13:50:11 |
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Basic information
Public title
Evaluation of cricoid pressure effect on tracheal intubation with McGRATH MAC
Acronym
Cricoid pressue effect on McGRATH intubation
Scientific Title
Evaluation of cricoid pressure effect on tracheal intubation with McGRATH MAC
Scientific Title:Acronym
Cricoid pressue effect on McGRATH intubation
Region
| Japan |
Condition
Condition
Patient who undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of cricoid pressure for McGRATH MAC mediated tracehal intubation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intubation time
Key secondary outcomes
number of insertion, number of tracehal tube advancement, postoperative hoarseness pharyngeal pain
VAS for laryngoscopy and tracheal 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
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Tracheal intubation is performed with 30N cricoid pressure with McGRATH MAC.
Interventions/Control_2
Tracheal intubation is performed without cricoid pressure with McGRATH MAC.
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
elective surgery
Key exclusion criteria
emergency operation
BMI>35
difficult tracehal intubation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuk city
TEL
0726-84-6361
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyasu Komasawa |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7Daigaku-machi, Takatsuki city
TEL
0726-84-6361
Homepage URL
ane078@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
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
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 | 08 | 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
Cricoid pressure lengethened the intubation time with McGRATH MAC.
First intubation success rate did notdiffer significantly.
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
| 2016 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 23 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 25 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 25 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 15 | Day |
Other
Other related information
Number of laryngoscopy did not differe signficantly.
POGO score also did not significantly change.
Management information
Registered date
| 2016 | Year | 01 | Month | 06 | Day |
Last modified on
| 2016 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022672
