UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006287
Receipt number R000007444
Scientific Title Lightwand-assisted intubation: a comparative study between obese and normal-weight patients
Date of disclosure of the study information 2011/09/05
Last modified on 2011/09/05 18:38:02

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Basic information

Public title

Lightwand-assisted intubation: a comparative study between obese and normal-weight patients

Acronym

lightwand and obesity

Scientific Title

Lightwand-assisted intubation: a comparative study between obese and normal-weight patients

Scientific Title:Acronym

lightwand and obesity

Region

Asia(except Japan)


Condition

Condition

patients undergone orotracheal intubation for general anesthesia were recruited into the study

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of the weight to the success rate and complications in the lightwand-guided intubation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Success rate and lightwand search time

Key secondary outcomes

complications


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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Patients with BMI more than or equal to 30 and less than 39.9

Interventions/Control_2

Patients with BMI more than or equal to 19 and less than 24.9

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

18 years-old <

Age-upper limit

60 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.History of difficult intubation, known airway abnormality, limited head-neck movement
2.Major surgery including cardiovascular, gastrointestinal, neurosurgical, or transplantation surgery
3.Possibility of pregnancy or lactating women
4.Those with preexisting coma or hoarseness
5.Those with oral or vocal cord surgery
6.Patient who has a history of mental illness

Target sample size

80


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

Organization

Third Military Medical University

Division name

Department of Anaesthesiology, Southwest Hospital,

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Anaesthesiology, Southwest Hospital,

Institute

Department

Personal name



Funding Source

Organization

Department of Anaesthesiology, Southwest Hospital,

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 09 Month 05 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

Enrolling by invitation

Date of protocol fixation

2011 Year 08 Month 25 Day

Date of IRB


Anticipated trial start date

2011 Year 09 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 09 Month 05 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=R000007444


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name