UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007849 |
|---|---|
| Receipt number | R000009249 |
| Scientific Title | The effect on respiratory support of biphasic cuirass ventilator |
| Date of disclosure of the study information | 2012/04/27 |
| Last modified on | 2014/10/18 14:02:09 |
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Basic information
Public title
The effect on respiratory support of biphasic cuirass ventilator
Acronym
The effect of biphasic cuirass ventilation
Scientific Title
The effect on respiratory support of biphasic cuirass ventilator
Scientific Title:Acronym
The effect of biphasic cuirass ventilation
Region
| Japan |
Condition
Condition
patients without respiratory disease who are scheduled for elective surgery; American Society of Anesthesiologist phisical status 1 or 2.
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the effects on respiratory support of biphasic cuirass ventilator
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
minute ventilation with or without biphasic cuirass ventilator
Key secondary outcomes
Base
Study type
Interventional
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
Biphasic cuirass ventirator, name of article RTX(21400BZY00382000)
From admission to operationg room to immediately before beginning of surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients without respiratory dysfunction who are scheduled for elective surgery; American Society of Anesthesiologist phisical status 1 or 2.
Key exclusion criteria
patients with respiratory dysfunction
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ritsuko Hirade |
Organization
Shimane university hospital
Division name
Surgical operation center
Zip code
Address
89-1 Enya-cho, Izumo city, Shimane, JAPAN
TEL
0853202295
richmond@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ritsuko Hirade |
Organization
Shimane university, Faculty of medicine
Division name
Department of Anesthesiology
Zip code
Address
89-1 Enya-cho, Izumo city, Shimane, JAPAN
TEL
0853202295
Homepage URL
richmond@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university, Faculty of medicine, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
Management information
Registered date
| 2012 | Year | 04 | Month | 27 | Day |
Last modified on
| 2014 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009249
