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
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
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
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
