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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027766
Receipt No. 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

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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
Email 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
Email nonhiraoka@yahoo.co.jp

Sponsor
Institute Jichi Medical University Hospital
Division of Anesthesiology, Department of Anesthesiology and Critical Care Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031816

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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