UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018922 |
|---|---|
| Receipt number | 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 21:59:15 |
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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
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
h-yuich@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Koshigaya Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021889
