UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009080 |
|---|---|
| Receipt number | R000010633 |
| Scientific Title | Effects of recruitment maneuver on functional residual volume and arterial oxygenation during one-lung ventilation |
| Date of disclosure of the study information | 2012/10/15 |
| Last modified on | 2019/02/26 19:25:01 |
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Basic information
Public title
Effects of recruitment maneuver on functional residual volume and arterial oxygenation during one-lung ventilation
Acronym
Recruitment maneuver during one-lung ventilation
Scientific Title
Effects of recruitment maneuver on functional residual volume and arterial oxygenation during one-lung ventilation
Scientific Title:Acronym
Recruitment maneuver during one-lung ventilation
Region
| Japan |
Condition
Condition
Lung tumor
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of recruitment maneuver on functional residual volume and arterial oxygenation during one-lung ventilation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional residual volume
Partial pressure of oxygen in arterial blood
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
Recruitment maneuver is performed to the dependent lung during one-lung ventilation (at 15 minutes) after the surgery started).
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo video-assisted thoracoscopic lung resection and require one-lung ventilation for an hour or longer are included.
Key exclusion criteria
Patients with ischemic heart disease, severe arrhythmia, unstable hemodynamic parameters, interstitial pneumonia, bulla in the dependent lung, history of lobectomy in the dependent lung, severe obstructive lung disease, or tracheostomy are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Ishikawa |
Organization
Tokyo Medical and Dental University Hospital of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5325
ishikawa.mane@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Ishikawa |
Organization
Tokyo Medical and Dental University Hospital of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
81-3-5803-5325
Homepage URL
ishikawa.mane@tmd.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
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 | 10 | Month | 15 | 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
| 2012 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | 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 | 10 | Month | 10 | Day |
Last modified on
| 2019 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010633
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