UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027766 |
|---|---|
| Receipt number | R000031816 |
| Scientific Title | study on the cuff pressure of endotracheal tube |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2017/06/15 13:11:18 |
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Basic information
Public title
study on the cuff pressure of endotracheal tube
Acronym
study on the cuff pressure of endotracheal tube
Scientific Title
study on the cuff pressure of endotracheal tube
Scientific Title:Acronym
study on the cuff pressure of endotracheal tube
Region
| Japan |
Condition
Condition
Disease with the need of the surgical intervention
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinical experience has been thought to correct cuff pressure (CP) more appropriately. Cuff volume (CV) is thought to affect CP during airway management. Moreover, it has still been unclear the relation between CP and CV under general anesthesia. We investigate the differences developing from experience about CP and CV using the endotracheal tube.
Basic objectives2
Others
Basic objectives -Others
It is recommended to maintain cuff pressure between 20 - 30 cm H2O. While insufficient cuff pressure(CP) of endotracheal tube may lead to aspiration, excessive CP may damage the tracheal epithelium. palpation method with pilot balloon did not result in adequate CP. The aim of this stusy is that this method is able to provide proper CP.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cuff pressure and cuff volume of single-lumen tube under general anesthesia, and experience level as an anesthesiologist
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were patients who were required elective and non-elective surgery under general anesthesia.
Key exclusion criteria
Exclusion criteria were patients who were in under 18 years, damaged cuff after intubation, intubated before anesthetic induction, tracheostomy, or administered N2O.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nozomu Hiraoka |
Organization
Jichi Medical University Hospital
Division name
Division of Anesthesiology, Department of Anesthesiology and Critical Care Medicine
Zip code
Address
Yakushiji 3311-1, Shimotsuke-shi, Tochigi-ken, Japan
TEL
0285-58-7383
nonhiraoka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomu Hiraoka |
Organization
Jichi Medical University Hospital
Division name
Division of Anesthesiology, Department of Anesthesiology and Critical Care Medicine
Zip code
Address
Yakushiji 3311-1, Shimotsuke-shi, Tochigi-ken, Japan
TEL
0285-58-7383
Homepage URL
nonhiraoka@yahoo.co.jp
Sponsor or person
Institute
Jichi Medical University Hospital
Division of Anesthesiology, Department of Anesthesiology and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University Hospital
Division of Anesthesiology, Department of Anesthesiology and Critical Care Medicine
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
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
| 2017 | Year | 07 | 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
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A total of 250 patients were enrolled in the current study.
Management information
Registered date
| 2017 | Year | 06 | Month | 15 | Day |
Last modified on
| 2017 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031816
