UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011326 |
|---|---|
| Receipt number | R000013250 |
| Scientific Title | Nitrous Oxide for Facilitating Lung Collapse during One-Lung Ventilation with Bronchial Blocker |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2013/08/02 23:50:48 |
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Basic information
Public title
Nitrous Oxide for Facilitating Lung Collapse during One-Lung Ventilation with Bronchial Blocker
Acronym
Nitrous Oxide for Lung Collapse with Bronchial Blocker
Scientific Title
Nitrous Oxide for Facilitating Lung Collapse during One-Lung Ventilation with Bronchial Blocker
Scientific Title:Acronym
Nitrous Oxide for Lung Collapse with Bronchial Blocker
Region
| Japan |
Condition
Condition
Thoracotomy or Thoracoscopic Surgery
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To varify our hypothesis that th use of nitrous oxide would lead to clinically relevent improvement of teh lung collapse during one-lung ventilation with a bronchial blocker
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare lung collapse scale at 5 minutes after opening the thorax between O2 group and N2O group
Key secondary outcomes
To compare lung collapse scale at one minute and 10 minutes after opening the pleura between O2 group and N2O group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Nitrous Oxide/Oxygen
Interventions/Control_2
Deflating the bronchial balloon/Non-deflating the bronchial balloon
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
Adult patients scheduled for elective thoracotomy or thoracoscopic surgery
Key exclusion criteria
1. Pleural adhesion anticipated on preoperative assesment
2. Evidence of bullae on chest computed tomography
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yoshimura |
Organization
Teikyo University Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-11-1 Kaga, Itabashi, Tokyo 173-8605, Japan
TEL
+81-3-3964-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Teikyo University Hospital
Division name
Department of Anesthesiology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Teikyo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2013 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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
| 2013 | Year | 07 | Month | 31 | Day |
Last modified on
| 2013 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013250
