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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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