UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031377
Receipt number R000035831
Scientific Title Investigation of the effect of lubrication with KY jelly on the increase in the cuff pressure of endotracheal tube during general anesthesia using nitrous oxide.
Date of disclosure of the study information 2018/03/01
Last modified on 2018/08/23 22:17:34

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Basic information

Public title

Investigation of the effect of lubrication with KY jelly on the increase in the cuff pressure of endotracheal tube during general anesthesia using nitrous oxide.

Acronym

Investigation of the effect of lubrication with KY jelly on the increase in the cuff pressure of endotracheal tube during general anesthesia using nitrous oxide.

Scientific Title

Investigation of the effect of lubrication with KY jelly on the increase in the cuff pressure of endotracheal tube during general anesthesia using nitrous oxide.

Scientific Title:Acronym

Investigation of the effect of lubrication with KY jelly on the increase in the cuff pressure of endotracheal tube during general anesthesia using nitrous oxide.

Region

Japan


Condition

Condition

The patients (ASA physical status 1 or 2), aged 20 to 80, scheduled for elective surgery under general anaesthesia requiring tracheal intubation.

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the cuff pressure behaviors of the endotracheal tube in the presence of lubrication with those in the absence of lubrication during general anesthesia using nitrous oxide.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The effect of lubrication with KY jelly on the
cuff pressure behaviors of the endotracheal tube during nitrous oxide exposure.

Key secondary outcomes

Sore throat and hoarseness after extubation.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Endotracheal tube with lubrication with 3 g of KY jelly.

Interventions/Control_2

Endotracheal tube without any lubrication.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients (ASA physical status 1 or 2), aged 20 to 80, scheduled for elective surgery under general anaesthesia requiring tracheal intubation.

Key exclusion criteria

ASA physical status more than 3, the history of PONV, laparoscopic surgery, the surgery in the prone position, major cardiovascular surgery, thoracic surgery, morbidly obese subjects (BMI>35), anticipated difficult intubation or the history of difficult intubation and the subjects in whom the use of nitrous oxide is considered inappropriate.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukihide Koyama

Organization

Mizonokuchi Hospital, Teikyo University School of Medicine

Division name

Anesthesiology

Zip code


Address

5-1-1, Futako, Takatsu-ku, Kawasaki, Kanagawa, Japan

TEL

044-844-3333

Email

yukihidekoyama1008@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Yukihide Koyama

Organization

Mizonokuchi Hospital, Teikyo University School of Medicine

Division name

Anesthesiology

Zip code


Address

5-1-1, Futako, Takatsu-ku, Kawasaki, Kanagawa, Japan

TEL

044-844-3333

Homepage URL


Email

yukihidekoyama1008@gmail.com


Sponsor or person

Institute

Department of Anesthesiology, Tomei Atsugi Hospital, Atsugi, Japan

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Tomei Atsugi Hospital, Atsugi, Japan

Organization

Division

Category of Funding Organization

Other

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

東名厚木病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2018 Year 03 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

Completed

Date of protocol fixation

2018 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 07 Month 31 Day

Date analysis concluded

2019 Year 08 Month 10 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 20 Day

Last modified on

2018 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035831


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name