UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005509
Receipt number R000006531
Scientific Title Does there exist an optimal lightwand bent length? A comparison of three different bent length
Date of disclosure of the study information 2011/04/26
Last modified on 2011/09/05 18:40:59

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Basic information

Public title

Does there exist an optimal lightwand bent length? A comparison of three different bent length

Acronym

Comparison of lightwand bent length

Scientific Title

Does there exist an optimal lightwand bent length? A comparison of three different bent length

Scientific Title:Acronym

Comparison of lightwand bent length

Region

Asia(except Japan)


Condition

Condition

orotracheal intubation

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate effects of three different bent length of the lightwand on endotracheal intubation in patients undergone general anesthesia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Success rate and lightwand search time

Key secondary outcomes

complication


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Interventions 1, the lightwand was bented according to the individual's thyroid prominence-to-mandibular angle distance.

Interventions/Control_2

Interventions 2, the lightwand was bented according to the individual's thyroid prominence-to-incisor distance.

Interventions/Control_3

In control, the lightwand was bented just proximal to the cuff.

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

18 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

patients undergone general anesthesia for elective surgery were recruited into the study

Key exclusion criteria

1. Cardiothoracic surgery
2. Oral and vocal cord surgery
3. Nasal intubation
4. Coma or hoarseness patients
5. Pregnancy or lactating women
6. Patient who has a history of mental illness

Target sample size

210


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chen Jie

Organization

Third Military Medical University

Division name

Department of Anaesthesiology, Southwest Hospital

Zip code


Address

Gaotanyan road, Shapingba, Chongqing, China

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Chen Jie

Organization

Third Military Medical University

Division name

Department of Anaesthesiology, Southwest Hospital

Zip code


Address

Gaotanyan road, Shapingba, Chongqing, China

TEL

+81-086(23)68754197

Homepage URL


Email

cjandsh2009@yahoo.cn


Sponsor or person

Institute

Department of Anaesthesiology, Southwest Hospital, Third Military Medical University

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 04 Month 26 Day


Related information

URL releasing protocol


Publication of results

Published


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

2011 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 03 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 04 Month 26 Day

Last modified on

2011 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006531


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name