UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparison of thyromental height (TMHT) in supine and upright positions in predicting difficult laryngoscopy: A prospective study.
Title of the study (Brief title)	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	Satoka Iwaoka
Organization	Tohokukosai Hospital
Division name	Department of Anesthesiology
Address	Kokubuncho2-3-11, Aobaku, Sendai, Miyagi, Japan
TEL	+08-22-227-2211
Email	satoka_raspberry@yahoo.co.jp

Public contact
Name of contact person	Mamoru Murakami
Organization	Tohokukosai Hospital
Division name	Department of Anesthesiology
Address	Kokubuncho2-3-11, Aobaku, Sendai, Miyagi, Japan
TEL	+08-22-227-2211
Homepage URL
Email	mmurakami-tohoku@umin.ac.jp

Sponsor
Institute	Tohokukosai Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026763