UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011925 |
|---|---|
| Receipt number | R000013922 |
| Scientific Title | Oxygen mask with capnometry is useful for CO2 monitoring after surgery. |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2015/08/24 11:42:22 |
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Basic information
Public title
Oxygen mask with capnometry is useful for CO2 monitoring after surgery.
Acronym
Usefulness of oxygen mask with capnometry
Scientific Title
Oxygen mask with capnometry is useful for CO2 monitoring after surgery.
Scientific Title:Acronym
Usefulness of oxygen mask with capnometry
Region
| Japan |
Condition
Condition
thoracic and abdominal tumor
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to make a study whether oxygen mask with capnometry is able to be alternative device with arterial blood gas analysis for assessment of respiratory condition after surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between end tidal carbon dioxide and partial pressure of carbon dioxide in blood. After administration of oxygen as 6 liter per min , 5 liter per min and 4 liter per min for 30 mins respectively, make comparison between end tidal and blood carbon dioxide.
Key secondary outcomes
Make comparison of dissociation between end tidal carbon dioxide and partial pressure of carbon dioxide during deep breath in oxygen administration as 6 liter per min, 5 liter per min and 4 liter per min.
Base
Study type
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Rather than the normal oxygen mask, to perform the oxygen administration by oxygen mask with capnometry.
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
I intend for adult patients who are extubated in the operating room in the postoperative patient Hepatobiliary and pancreatic disease.
Key exclusion criteria
I exclude patients who are state of consternation and respiratory depression due to chronic obstructive pulmonary disease and lung resection, under 18 years of age and serious injuries lung disease.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Takaki |
Organization
Yokohama City University Hospital
Division name
Intensive Care Unit
Zip code
Address
3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan
TEL
045-787-2800
shunty5323@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Takaki |
Organization
Yokohama City University Hospital
Division name
Intensive Care Unit
Zip code
Address
3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan
TEL
0457872800
Homepage URL
shunty5323@gmail.com
Sponsor or person
Institute
Yokohama City University Hospital Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital Department of Anesthesiology
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://rc.rcjournal.com/content/early/2015/01/13/respcare.03557
Number of participants that the trial has enrolled
Results
Oxygen mask capnometry type may be useful for respiratory monitoring.
Absolute value of EtCO2 was widely variable, therefore it is suitable for monitoring of transition of CO2 value.
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
Main results already published
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 10 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 01 | Day |
Last modified on
| 2015 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013922
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
