UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023219 |
|---|---|
| Receipt number | R000026763 |
| Scientific Title | A comparison of thyromental height (TMHT) in supine and upright positions in predicting difficult laryngoscopy: A prospective study. |
| Date of disclosure of the study information | 2016/07/31 |
| Last modified on | 2017/11/25 14:18:39 |
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Basic information
Public title
A comparison of thyromental height (TMHT) in supine and upright positions in predicting difficult laryngoscopy: A prospective study.
Acronym
A comparison of thyromental height (TMHT) in supine and upright positions in predicting difficult laryngoscopy
Scientific Title
A comparison of thyromental height (TMHT) in supine and upright positions in predicting difficult laryngoscopy: A prospective study.
Scientific Title:Acronym
A comparison of thyromental height (TMHT) in supine and upright positions in predicting difficult laryngoscopy
Region
| Japan |
Condition
Condition
Patients who need endotracheal intubation under general anesthesia for elective surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to compare thyromental height (TMHT) in upright positions with modified Mallampati test (MMT), thyromental distance (TMD), ratio of height to TMD (RHTMD) and TMHT in supine position from the viewpoint of the predictability of difficult laryngoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint is area under the curve (AUC) of ROC curves, which consist of TMHT in upright positions (or other predictive tests for difficult laryngoscopy) and Cormack-Lehane classification.
Key secondary outcomes
Base
Study type
Observational
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
general anesthesia
endotracheal intubation
elective surgery
Key exclusion criteria
1.Awake intubation
2.Emergency surgery
3.BMI > 35
4.Impossible to evaluate modified Mallampati test
5.Congenital diseases predicted to be difficult laryngoscopy
6.Impossible to be standing or sitting positions
7.Who needs to rapid sequence induction
Target sample size
670
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoka Iwaoka |
Organization
Tohokukosai Hospital
Division name
Department of Anesthesiology
Zip code
Address
Kokubuncho2-3-11, Aobaku, Sendai, Miyagi, Japan
TEL
+08-22-227-2211
satoka_raspberry@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Murakami |
Organization
Tohokukosai Hospital
Division name
Department of Anesthesiology
Zip code
Address
Kokubuncho2-3-11, Aobaku, Sendai, Miyagi, Japan
TEL
+08-22-227-2211
Homepage URL
mmurakami-tohoku@umin.ac.jp
Sponsor or person
Institute
Tohokukosai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
東北公済病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 31 | 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
| 2016 | Year | 07 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 11 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 25 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 05 | Day |
Other
Other related information
Predictor variables are
1)Thyromental height in upright positions
2)Modified Mallmpati test
3)Thyromental distance
4)Ratio of height to thyromental distance
5)Thyromental height in supine position
Outcome variable is Cormack-Lehane classification
Management information
Registered date
| 2016 | Year | 07 | Month | 18 | Day |
Last modified on
| 2017 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026763
