UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007963 |
|---|---|
| Receipt number | 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 11:13:10 |
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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
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
ytagaito@hotmail.com
Sponsor or person
Institute
Teikyo University Chiba Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009372
