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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018922
Receipt No. R000021889
Scientific Title Comparison of the Pentax AWS s-100 and the new Pentax AWS s-200 in the success rate of tracheal intubation
Date of disclosure of the study information 2015/12/01
Last modified on 2018/10/04

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Basic information
Public title Comparison of the Pentax AWS s-100 and the new Pentax AWS s-200 in the success rate of tracheal intubation
Acronym Comparison of the Pentax AWS s-100 and the new Pentax AWS s-200 in the success rate of tracheal intubation
Scientific Title Comparison of the Pentax AWS s-100 and the new Pentax AWS s-200 in the success rate of tracheal intubation
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuichi Hashimoto
Organization Dokkyo Medical University Koshigaya Hospital
Division name Department of Anesthesia
Zip code
Address 2-1-50 Minami Koshigaya Saitama Japan
TEL 048-965-4948
Email h-yuich@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Hashimoto
Organization Dokkyo Medical University Koshigaya Hospital
Division name Department of Anesthesia
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2015 Year 11 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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