UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the Pentax AWS s-100 and the new Pentax AWS s-200 in the success rate of tracheal intubation
Title of the study (Brief title)	Comparison of the Pentax AWS s-100 and the new Pentax AWS s-200 in the success rate of tracheal intubation
Region	Japan

Condition
Condition	The Pentax AWS s-100 The Pentax AWS s-200
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The Pentax AWS s-200 is a new videolaryngoscope released in 2014. It is the videolaryngoscope improved on the original AWS (AWS s-100). The AWS s-100 is widespread , facilitates trachial intubation, and it is available for everyone who are inexperienced in tracheal intubation. As we position targetmark with glottis, intubation is easy by AWS s-100. But , previously we used AWS s-200 and, tried intubating 20 adult patients with no airway disease. we successed tracheal intubation in all patients. But, we could not intubate smoothly in 10 patients by first attempt. Tracheal tube hit artenoids in these patients, so we adjusted tube position by pressing the patient's neck. We thought the targetmark may be incorrect position in AWS s-200 (in press). We make a comparative study of the Pentax AWS s-100 and the new Pentax AWS s-200 in the success rate of tracheal intubation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is the success rate of intubation using AWS s-100 or AWS s-200, and we compare the success rate. We measure the time for traceal intubation(start laryngoscope(by AWS) to the tracheal tube through the glottis). In many reports, the success rate was higher than 95% in first attempt, and average time for traceal intubation was 30 sec by AWS s-100. In our study, we define the intubation is successful within 60 sec by AWS(s-100 or s-200), and failure over 60 sec. If the intubation was failure, we record the reason (tracheal tube hit artenoids et, al). We could not intubate within 60 sec, we can adjusted tube position by pressing the patient's neck, and try the tracheal intubation. Fisher's test is used to compare the success rate of the intubation by AWS s-100 or AWS s-200, and 95% CI for differences in the success rates between the two occasions.
Key secondary outcomes	Comparison of the time for tracheal intubation by s-100, or s-200. Comparison of the view of the glottis by s-100, or s-200.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Tracheal intubation by AWS s-100 in 35 adult patients (ASA physical status 1-2, aged over 20 years) scheduled for elective surgery in under general anaesthesia, in 1 April 2016 to 31 December 2016. We selected 35 patients in this occasion by randomisation using a sealed envelope.
Interventions/Control_2	Tracheal intubation by AWS s-200 in 35 adult patients (ASA physical status 1-2, aged over 20 years) scheduled for elective surgery in under general anaesthesia, in 1 April 2016 to 31 December 2016. We selected 35 patients in this occasion by randomisation using a sealed envelope.
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	70 adult patients (ASA physical status 1-2, aged over 20 years) scheduled for elective surgery in under general anaesthesia,
Key exclusion criteria	Patients with any pathology of the neck or upper respiratory tract or at risk of pulmonary aspiration of gastric contents were excluded. Patients in whom ventilation through a facemask and tracheal intubation were predicted to be difficult were also not taken into the study.
Target sample size	70

Research contact person
Name of lead principal investigator	Yuichi Hashimoto
Organization	Dokkyo Medical University Koshigaya Hospital
Division name	Department of Anesthesia
Address	2-1-50 Minami Koshigaya Saitama Japan
TEL	048-965-4948
Email	h-yuich@dokkyomed.ac.jp

Public contact
Name of contact person	Yuichi Hashimoto
Organization	Dokkyo Medical University Koshigaya Hospital
Division name	Department of Anesthesia
Address	2-1-50 Minami Koshigaya Saitama Japan
TEL	048-965-4948
Homepage URL
Email	h-yuich@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University Koshigaya Hospital
Institute
Department

Funding Source
Organization	no
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	獨協医科大学越谷病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 30 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 06 Day
Last modified on	2018 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021889