UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005715
Receipt number R000006756
Scientific Title Efficacy of Coopdech videolaryngoscope : Comparisons with a Macintosh laryngoscope and the Airway Scope in a manikin with difficult airways
Date of disclosure of the study information 2011/06/03
Last modified on 2011/06/03 16:33:01

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Basic information

Public title

Efficacy of Coopdech videolaryngoscope : Comparisons with a Macintosh laryngoscope and the
Airway Scope in a manikin with difficult airways

Acronym

Efficacy of Coopdech videolaryngoscope : Comparisons with a Macintosh laryngoscope and the
Airway Scope in a manikin with difficult airways

Scientific Title

Efficacy of Coopdech videolaryngoscope : Comparisons with a Macintosh laryngoscope and the
Airway Scope in a manikin with difficult airways

Scientific Title:Acronym

Efficacy of Coopdech videolaryngoscope : Comparisons with a Macintosh laryngoscope and the
Airway Scope in a manikin with difficult airways

Region

Japan


Condition

Condition

a manikin with difficult airways

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The main aim of the study was to assess the efficacy of the Coopdech Videolaryngoscope Portable by comparing it with the Macintosh laryngoscope and with an established videolaryngoscope, the Airway Scope in simulated difficult airways.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The main aim of the study was to compare the success rate of tracheal intubation (within 120 s) between the three laryngoscopes.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

5

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

manikin with normal airway.
the view of the glottis at laryngoscopy was graded.The time to see the glottis, the time to intubate the trachea and the success rate of tracheal intubation were recorded.

Interventions/Control_2

manikin with tongue oedema.
the view of the glottis at laryngoscopy was graded.The time to see the glottis, the time to intubate the trachea and the success rate of tracheal intubation were recorded.

Interventions/Control_3

manikin with cervical spine rigidity.
the view of the glottis at laryngoscopy was graded.The time to see the glottis, the time to intubate the trachea and the success rate of tracheal intubation were recorded.

Interventions/Control_4

manikin with pharyngeal obstruction.
the view of the glottis at laryngoscopy was graded.The time to see the glottis, the time to intubate the trachea and the success rate of tracheal intubation were recorded.

Interventions/Control_5

manikin with laryngospasm.
the view of the glottis at laryngoscopy was graded.The time to see the glottis, the time to intubate the trachea and the success rate of tracheal intubation were recorded.

Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Fifty medical residents, who were rotating to our department of Anaesthetics, participated to this study. All participants had performed less than 10 tracheal intubations within the initial 1 mo of training.

Key exclusion criteria

medical residents, who were not rotating to our department of Anaesthetics

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoyuki Saito

Organization

Dokkyo Medical University Koshigaya Hospital

Division name

Department of Anaesthesiology

Zip code


Address

2-1-50 Minamikoshigaya, Koshigaya City, Saitama, 343-8555, Japan.

TEL

048-965-1111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Tomoyuki Saito

Organization

Dokkyo Medical University Koshigaya Hospital

Division name

Department of Anaesthesiology

Zip code


Address

2-1-50 Minamikoshigaya, Koshigaya City, Saitama, 343-8555, Japan

TEL

048-965-1111

Homepage URL


Email

s-tomo@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University Koshigaya Hospital

Institute

Department

Personal name



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


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



Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 03 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

2008 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 01 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

2011 Year 06 Month 03 Day

Last modified on

2011 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006756


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name