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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031377
Receipt No. 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

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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
Institute Department of Anesthesiology, Tomei Atsugi Hospital, Atsugi, Japan
Institute
Department

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
URL(English) https://upload.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


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