UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014062 |
|---|---|
| Receipt number | R000016365 |
| Scientific Title | Evaluation of a new nasal cannula based capnometry device for continuous monitoring of carbon dioxide during different breathing patterns in patients extubated after abdominal surgery: A prospective observational study. |
| Date of disclosure of the study information | 2014/05/26 |
| Last modified on | 2015/09/25 13:32:34 |
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Basic information
Public title
Evaluation of a new nasal cannula based capnometry device for continuous monitoring of carbon dioxide during different breathing patterns in patients extubated after abdominal surgery: A prospective observational study.
Acronym
Evaluation of a new nasal cannula based capnometry device for continuous monitoring of carbon dioxide.
Scientific Title
Evaluation of a new nasal cannula based capnometry device for continuous monitoring of carbon dioxide during different breathing patterns in patients extubated after abdominal surgery: A prospective observational study.
Scientific Title:Acronym
Evaluation of a new nasal cannula based capnometry device for continuous monitoring of carbon dioxide.
Region
| Japan |
Condition
Condition
abdominal surgical patients
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
we aimed to evaluate usefulness of nasal canulae with a carbon dioxide sampling port (nasal canulae capnometry typeR) in extubated patients who had received abdominal surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
We compare EtCO2 measured by capnometry by using an nasal canulae with a carbon dioxide sampling port and partial pressure of carbon dioxide (PaCO2)
Key secondary outcomes
we investigated whether spontaneous deep breathing affected dissociation between PaCO2 and EtCO2.
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
patients who were performed abdominal surgery, and admitted intensive care unit after extubation.
Key exclusion criteria
Patients who have respiratory comorbidity and desaturated below 90% at nasal canula were excluded.
Target sample size
30
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 Medicine
Zip code
Address
3-9 Fukuura Kanazawaku Yokohama city
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 Medicine
Zip code
Address
3-9 Fukuura Kanazawaku Yokohama city
TEL
045-787-2800
Homepage URL
shunty5323@gmail.com
Sponsor or person
Institute
Yokohama City University Hospital Department Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital Department 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
| 2014 | Year | 05 | Month | 26 | 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
EtCO2 measured by nasal cannula capnometry type was significantly correlated with PaCO2 by blood gas analysis. However, dissociation was widely variated. Therefore, it is difficult to predict absolute PaCO2 value with using EtCO2 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
| 2014 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
EtCO2 and PaCO2 are assessed.
Management information
Registered date
| 2014 | Year | 05 | Month | 25 | Day |
Last modified on
| 2015 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016365
