UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031992 |
|---|---|
| Receipt number | R000036516 |
| Scientific Title | The estimation of partial pressure of arterial carbon dioxide assessed by volumetric capnography |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/03/08 01:50:05 |
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Basic information
Public title
The estimation of partial pressure of arterial carbon dioxide assessed by volumetric capnography
Acronym
The estimation of partial pressure of arterial carbon dioxide assessed by volumetric capnography
Scientific Title
The estimation of partial pressure of arterial carbon dioxide assessed by volumetric capnography
Scientific Title:Acronym
The estimation of partial pressure of arterial carbon dioxide assessed by volumetric capnography
Region
| Japan |
Condition
Condition
Adult patients undergoing elective surgery over 6 hours under general anesthesia
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Obstetrics and Gynecology | Orthopedics | Anesthesiology |
| Neurosurgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the estimated arterial partial pressure of carbon dioxide assessed by volumetric capnography to arterial partial pressure of carbon dioxide measured by arterial blood gas.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation coefficient for the estimated arterial partial pressure of carbon dioxide assessed by volumetric capnography and arterial partial pressure of carbon dioxide measured by arterial blood gas.
Key secondary outcomes
dead space to tidal volume ratio
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients scheduled for elective surgery in the supine position
Key exclusion criteria
Patients with forced expiratory volume in one second < 70%
Patients undergoing one lung ventilation
Patients undergoing cardiopulmonary bypass
Patients with abnormal pulmonary blood flow by congenital heart disease
Patients with less than 50% of ejection fraction
Patients whose invasive blood pressure monitoring can not measured
Patients with difficult airway
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Araki Hiroshi |
Organization
National Hospital Organization(NHO) Nagasaki Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-1001-1 Kubara,Omura,Nagasaki,856-8562,Japan
TEL
0957-52-3121
haraki@nagasaki-mc.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Araki Hiroshi |
Organization
National Hospital Organization(NHO) Nagasaki Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-1001-1 Kubara,Omura,Nagasaki,856-8562,Japan
TEL
0957-52-3121
Homepage URL
haraki@nagasaki-mc.com
Sponsor or person
Institute
National Hospital Organization(NHO) Nagasaki Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | 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
Observational study
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036516
