UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021506
Receipt number R000023878
Scientific Title Comparison of PVC and Sn stylet for postoperative pharyngeal pain and hoarseness.
Date of disclosure of the study information 2016/03/17
Last modified on 2016/08/10 07:36:06

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Basic information

Public title

Comparison of PVC and Sn stylet for postoperative pharyngeal pain and hoarseness.

Acronym

Comparison of pharyngeal pain and hoarseness by stylet

Scientific Title

Comparison of PVC and Sn stylet for postoperative pharyngeal pain and hoarseness.

Scientific Title:Acronym

Comparison of pharyngeal pain and hoarseness by stylet

Region

Japan


Condition

Condition

Patient who undergo general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of PVC and Sn stylet for postoperative pharyngeal pain and hoarseness.

Basic objectives2

Others

Basic objectives -Others

Force on stylet extubation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of hoarseness and pharyngeal pain on next morning

Key secondary outcomes

Force on stylet extubation


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

Placebo

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 with PVC stylet

Interventions/Control_2

Tracheal intubation with Sn stylet

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who undergo general anesthesia with tracheal intubation

Key exclusion criteria

Difficult airway
emergency operation

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiaki Minami

Organization

Osaka Medical College

Division name

Anesthesiology

Zip code


Address

2-7 Daigaku-machi, Takatsuk city

TEL

0726-84-6361

Email

ane022@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuyasu Komasawa

Organization

Osaka Medical College

Division name

Anesthesiology

Zip code


Address

2-7Daigaku-machi, Takatsuki city

TEL

0726-84-6361

Homepage URL


Email

ane078@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College

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

2016 Year 03 Month 17 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

The incidence of pharyngeal pain or hoarseness was significantly smaller in Sn stylet than in PVC stylet.

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

2016 Year 03 Month 07 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date

2016 Year 08 Month 10 Day

Date of closure to data entry

2016 Year 08 Month 11 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Stylet extraction force was significantly smaller in the Sn stylet than in the PVC stylet.


Management information

Registered date

2016 Year 03 Month 17 Day

Last modified on

2016 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023878


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name