UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025266
Receipt No. R000029011
Scientific Title A study on changes in endotracheal tube cuff pressure during tracheal intubation
Date of disclosure of the study information 2016/12/14
Last modified on 2019/03/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study on changes in endotracheal tube cuff pressure during tracheal intubation
Acronym A study on changes in endotracheal tube cuff pressure during tracheal intubation
Scientific Title A study on changes in endotracheal tube cuff pressure during tracheal intubation
Scientific Title:Acronym A study on changes in endotracheal tube cuff pressure during tracheal intubation
Region
Japan

Condition
Condition adult patients presenting for elective surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test if endotracheal tube cuff pressure profile could enable us to detect esophageal intubation during tracheal intubation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes endotracheal tube cuff pressure profile during intubation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 inflation of endotracheal tube cuff with 1ml of air before tracheal intubation
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria American Society of Anesthesiologists physical status 1-2 patients presenting for elective surgery under general anesthesia with orotracheal intubation
Key exclusion criteria Those who have any wound or lesion or abnormality or foreign objects at maxillofacial or cervical or upper airway or respiratory region. Pregnant women. Those who cannot express their will to participate in the study by themselves. Emergent operations. Full stomach condition or alike (e.g. obese patients whose body mass index is above 35, those who have large abdominal mass, etc.)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yugo Tagaito
Organization Teikyo University Chiba Medical Center
Division name Department of Anesthesiology
Zip code
Address 3426-3 Anesaki, Ichihara-city, Chiba, Japan
TEL 0436-62-1211
Email ytagaito@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yugo Tagaito
Organization Teikyo University Chiba Medical Center
Division name Department of Anesthesiology
Zip code
Address 3426-3 Anesaki, Ichihara-city, Chiba, Japan
TEL 0436-62-1211
Homepage URL
Email ytagaito@yahoo.co.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization None
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
2016 Year 12 Month 14 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
2016 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2019 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029011

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.