UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035108 |
|---|---|
| Receipt number | R000039815 |
| Scientific Title | Assessments of mask ventilation efficiency during anesthesia induction with using capnogram |
| Date of disclosure of the study information | 2018/12/03 |
| Last modified on | 2020/10/24 08:45:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessments of mask ventilation efficiency during anesthesia induction with using capnogram
Acronym
Assessments of mask ventilation efficiency with using capnogram
Scientific Title
Assessments of mask ventilation efficiency during anesthesia induction with using capnogram
Scientific Title:Acronym
Assessments of mask ventilation efficiency with using capnogram
Region
| Japan |
Condition
Condition
patient under going general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We test a hypothesis that the value of end-tidal carbon dioxide concentration predicts tidal volume achieved by mask ventilation during anesthesia induction when the phase II capnogram waveform is only detected.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
End tidal carbon dioxide concentration
Key secondary outcomes
tidal volume, back ground parameters, results of preoperative sleep study, and respiratory variables during mask ventilation
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
Patients scheduled to undergo general anesthesia
Key exclusion criteria
1) Planned intubation with consciousness
2) Full Stomac
3) Patients who have a fistula in the respiratory tract such as tracheostomy and tracheoesophageal fistula
4) Emergency operation
5)Allergy to drugs scheduled for use
6) Patients who have dementia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shiroh |
| Middle name | |
| Last name | Isono |
Organization
Chiba University
Division name
Graduate School of Medicine, Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana Chuo Chiba
TEL
0432227171
shirohisono@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Taiichiro |
| Middle name | |
| Last name | Hayashida |
Organization
Chiba University
Division name
Graduate School of Medicine, Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana Chuo Chiba
TEL
0432227171
Homepage URL
anpapal.71@gmail.com
Sponsor or person
Institute
Chiba University
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
Chiba University Hospital
Address
1-8-1 Inohana Chuo Chiba
Tel
0432227171
chibacrc@mac.com
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 | 12 | Month | 03 | 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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 22 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 23 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 30 | Day |
Other
Other related information
Capnogram waveform, end-tidal carbon dioxide concentration, and tidal volume during mask ventilation during planned anesthesia induction are continuously measured with using patient monitoring system. The composite video images of the patient monitor display and the video camera image of the anesthesiologist are continuously recorded during anesthesia induction and used for later data analyses.
Management information
Registered date
| 2018 | Year | 12 | Month | 02 | Day |
Last modified on
| 2020 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039815
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
