UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009685 |
|---|---|
| Receipt number | R000011359 |
| Scientific Title | Non-invasive evaluation of work of breathing during weaning from ventilatory support. |
| Date of disclosure of the study information | 2013/01/04 |
| Last modified on | 2021/07/13 09:26:55 |
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Basic information
Public title
Non-invasive evaluation of work of breathing during weaning from ventilatory support.
Acronym
Non-invasive evaluation of work of breathing during weaning from ventilatory support.
Scientific Title
Non-invasive evaluation of work of breathing during weaning from ventilatory support.
Scientific Title:Acronym
Non-invasive evaluation of work of breathing during weaning from ventilatory support.
Region
| Japan |
Condition
Condition
patients undergoing cardiac surgery
Classification by specialty
| Cardiovascular surgery | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate work of breathing non-invasively during weaning process from ventilatory support after cardiac surgery.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between oxygen consumption and the spontaneous breathing, consciousness and oral intake.
Key secondary outcomes
Relationship between oxygen consumption and the length of ventilatory support and length of ICU stay.
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 undergoing elective cardiac surgery at the study institution.
Key exclusion criteria
Re-do surgery
Chronic renal failure necessitating hemodialysis
Preoperative cardiorespiratory status is below 4METS.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
153-8515
Address
2-17-6 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
ykotake@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
153-8515
Address
2-17-6 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
ykotake@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Ohashi Medical Center
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
IRB, Toho University Ohashi Medical Center
Address
2-17-6, Ohashi, Meguro, Tokyo, Japan
Tel
03-3468-1251
secretary@oha.toho-u.ac.jp
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
東邦大学医療センター大橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
Number of participants that the trial has enrolled
0
Results
interrupted
Results date posted
| 2021 | Year | 07 | Month | 13 | Day |
Results Delayed
Results Delay Reason
interrupted
Date of the first journal publication of results
Baseline Characteristics
no enrollment
Participant flow
no enrollment
Adverse events
no enrollment
Outcome measures
no enrollment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 30 | Day |
Other
Other related information
oxygen consumption
ventilator setting and respiratory parameters
consciousness level
timing of ventilator weaning
timing and contents of oral intake
Management information
Registered date
| 2013 | Year | 01 | Month | 04 | Day |
Last modified on
| 2021 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011359
