UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012261 |
|---|---|
| Receipt number | R000014339 |
| Scientific Title | The effect of continuous positive airway pressure (CPAP) on aryerial oxygenation during one-lung ventilation. |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2014/06/11 15:41:45 |
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Basic information
Public title
The effect of continuous positive airway pressure (CPAP) on aryerial oxygenation during one-lung ventilation.
Acronym
The effect of continuous positive airway pressure (CPAP) on aryerial oxygenation during one-lung ventilation.
Scientific Title
The effect of continuous positive airway pressure (CPAP) on aryerial oxygenation during one-lung ventilation.
Scientific Title:Acronym
The effect of continuous positive airway pressure (CPAP) on aryerial oxygenation during one-lung ventilation.
Region
| Japan |
Condition
Condition
Patients that undergoing surgery for lung tumor requring one lung ventilation.
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To measure changes in blood oxygen partial pressure for changing of administration oxygen concentration of CPAP during the one lung ventilation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood oxygen partial pressure
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Continuous positive airway pressure of oxygen concentration 100%
Interventions/Control_2
Continuous positive airway pressure of oxygen concentration 50%
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with lung tumor
Key exclusion criteria
History of ischemic heart disease.
History of ischemic brain disease.
NYHA (New York Heart Association) classification is greater than 2.
Hugh-Jones classification is greater than 2.
SPO2 is less than 95%.
PaO2 is less than 70mmHg.
BMIis greater than 29 kg/m2.
ASA-PS classificationis greater than 2.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kazuhiro kito |
Organization
Gifu University Hospital
Division name
Department of Anesthesiology and pain medicine
Zip code
Address
1-1 yanagido gifu city
TEL
058-230-6404
kitokazu1979@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kazuhiro kito |
Organization
Gifu University Hospital
Division name
Department of Anesthesiology and pain medicine
Zip code
Address
1-1 yanagido gifu city
TEL
058-230-6404
Homepage URL
kitokazu1979@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology and Pain medicine, Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
NO
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
| 2014 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 08 | 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
| 2013 | Year | 11 | Month | 11 | Day |
Last modified on
| 2014 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014339
