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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007963
Receipt No. R000009372
Scientific Title Usefulness of intra endotracheal tube pressure monitoring for detecting esophageal intubation during tracheal intubation trial with oxygen insufflation
Date of disclosure of the study information 2012/05/15
Last modified on 2013/11/19

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Basic information
Public title Usefulness of intra endotracheal tube pressure monitoring for detecting esophageal intubation during tracheal intubation trial with oxygen insufflation
Acronym Intra endotracheal tube pressure monitoring for detecting esophageal intubation
Scientific Title Usefulness of intra endotracheal tube pressure monitoring for detecting esophageal intubation during tracheal intubation trial with oxygen insufflation
Scientific Title:Acronym Intra endotracheal tube pressure monitoring for detecting esophageal intubation
Region
Japan

Condition
Condition ASA physical status 1 or 2 adult patients undergoing general anesthesia
Classification by specialty
Anesthesiology Emergency medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test if intra endotracheal tube pressure monitoring enables us to detect esophageal intubation during trachal intubation procedure when oxygen is insufflated through endotracheal tube
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in intra endotracheal tube pressure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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 Oxygen insufflation through endotracheal tube, 6 litter per minute
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
100 years-old >
Gender Male and Female
Key inclusion criteria ASA physical status 1 or 2
Key exclusion criteria patients with dementia, mental retardation, those unable to provide informed consent
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 Dept. of Anesthesiology
Zip code
Address 3426-3 Anesaki, Ichihara-city, Chiba, Japan
TEL 0436-63-1211
Email ytagaito@hotmail.com

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

Sponsor
Institute Teikyo University Chiba Medical Center
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 帝京大学ちば総合医療センター(千葉県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 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
2012 Year 05 Month 15 Day
Last modified on
2013 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009372

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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