UMIN-CTR Clinical Trial

Basic information
Public title	A study of difficult tracheal intubations using McGRATH-MAC in patients undergoing elective surgeries
Acronym	A study of difficult tracheal intubations using McGRATH-MAC in patients undergoing elective surgeries
Scientific Title	A study of difficult tracheal intubations using McGRATH-MAC in patients undergoing elective surgeries
Scientific Title:Acronym	A study of difficult tracheal intubations using McGRATH-MAC in patients undergoing elective surgeries
Region	Japan

Condition
Condition	Elective surgeries under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate failure rates of the first tracheal intubation for elective surgeries using McGRATH-MAC in Japan
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Failure rates of the first tracheal intubation performed by anethesiologists using McGRATH-MAC
Key secondary outcomes	Factors related to the first tracheal intubation failure Management for the tracheal intubation failure Complications with the tracheal intubation Failure rates of the first tracheal intubation performed by non-anesthesiologists

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	20 years-old <=
Age-upper limit	120 years-old >=
Gender	Male and Female
Key inclusion criteria	All patients undergoing elective surgeries and orotracheal intubation performed by anesthesiologists or non-anethesiologists supervised by anesthesiologists
Key exclusion criteria	Patients younger than 20 years-old Patients undergoing awake intubation Patients undergoing slow induction or rapid sequence induction Patients undergoing tracheotomy Patients who have already received tracheotomy Patients undergoing tracheal intubation without neuromuscular blocking agents
Target sample size	3000

Research contact person
Last name of lead principal investigator	1st name Motoki Middle name Last name Namekawa
Organization	Kurashiki Central Hospital
Division name	Department of Anesthesiology
Zip code	710-8602
Address	1-1-1 Miwa, Kurashiki, Okayama, 710-8602 Japan
TEL	086-422-0210
Email	mn14383@kctnet.or.jp

Public contact
1st name of contact person	1st name Motoki Middle name Last name Namekawa
Organization	Kurashiki Central Hospital
Division name	Department of Anesthesiology
Zip code	710-8602
Address	1-1-1 Miwa, Kurashiki, Okayama, 710-8602 Japan
TEL	086-422-0210
Homepage URL
Email	mn14383@kctnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital Department of Anesthesiology
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)

IRB Contact (For public release)
Organization	Kurashiki Clinical Research Institute
Address	1-1-1 Miwa, Kurashiki, Okayama, 710-8602 Japan
Tel	086-422-0210
Email	igakuken@kchnet.or.jp

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	2017 Year 02 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	Completed
Date of protocol fixation	2016 Year 12 Month 21 Day
Date of IRB	2016 Year 12 Month 21 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

A single center, prospective, observational study Research period: From February 1, 2017 to February 28, 2019 Estimated number of cases: 3,000 cases Estimation of a sample size: We estimated failure rates of 1% for the first intubation. We calculated 3,000 cases as a sample size based on 95% confident interval of 1%. Key inclusion criteria: All patients undergoing elective surgeries and orotracheal intubation performed by anesthesiologists or non-anethesiologists supervised by anesthesiologists Key exclusion criteria: Patients younger than 20 years-old Patients undergoing awake intubation Patients undergoing slow induction or rapid sequence induction Patients undergoing tracheotomy Patients who have already received tracheotomy Patients undergoing tracheal intubation without neuromuscular blocking agents Measurements: Age, Sex, Height, Weight, Primary disease, Department, Type of operation, Type of anesthesia, ASA class, Operation time, Anesthesia time Denture use, Upset teeth, Protector of teeth, Snoring, Sleep apnea syndrome, Length of mouth opening, Mallampati class, Upper lip bite class, Neck perimeter, Thyromental distance, Sternomental distance, Limitation of neck extension, Cervical disease, Anatomical abnormalities in the neck Length of mouth opening after neuromuscular block, Difficulty in mask ventilation, Cricoid pressure during tracheal intubation, Positioning of neck, Number of intubation attempt, Cause of intubation failure, Management for intubation failure, Operator of intubation, Cormack grade, Tube size, Tube type, Stylet, McGRATH-MAC blade size, Reason for use of other devices Desaturation (SpO2<90%), Hypertension (systolic blood pressure>180mmHg), and Tachycardia (heart rate>130/min) during intubation period, Esophageal intubation, Aspiration, Injuries of lip, pharynx, trachea, and teeth, Steroid administration for laryngeal edema, Re-intubation for airway stenosis or edema

Management information
Registered date	2017 Year 02 Month 01 Day
Last modified on	2019 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029833