UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025195 |
|---|---|
| Receipt number | R000028963 |
| Scientific Title | a comparison of the dynamics effects of cough assistance and manual alveolar recruitment maneuver in surgical patients |
| Date of disclosure of the study information | 2016/12/09 |
| Last modified on | 2016/12/09 10:26:17 |
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Basic information
Public title
a comparison of the dynamics effects of cough assistance and manual alveolar recruitment
maneuver in surgical patients
Acronym
a comparison of the dynamics effects of cough assistance and manual alveolar recruitment
maneuver in surgical patients
Scientific Title
a comparison of the dynamics effects of cough assistance and manual alveolar recruitment
maneuver in surgical patients
Scientific Title:Acronym
a comparison of the dynamics effects of cough assistance and manual alveolar recruitment
maneuver in surgical patients
Region
| Japan |
Condition
Condition
under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
safety of cough assistance in surgical patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the dynamics effects of cough assistance in surgical patients
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
| Maneuver |
Interventions/Control_1
cough assistance for 30 seconds during general anesthesia
Interventions/Control_2
manual alveolar recruitment maneuver for 30 seconds during general anesthesia
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
American Society of Anesthesiologists physical status (ASA PS)1-2 patients under general anesthesia
Key exclusion criteria
patients with cardiac deseases
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SATOMI TAHARA |
Organization
Almeida memorial hospital
Division name
department of anesthesiology
Zip code
Address
1509-2 miyazaki Oita-city
TEL
0975693121
satahara@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirokazu Kato |
Organization
Almeida Memorial Hospital
Division name
department of pharmacy
Zip code
Address
1509-2 miyazaki Oita-city
TEL
0975693121
Homepage URL
hi_katou@almeida.oita.med.or.jp
Sponsor or person
Institute
Almeida memorial hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
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
大分市医師会立 アルメイダ病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 09 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | 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
| 2016 | Year | 12 | Month | 09 | Day |
Last modified on
| 2016 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028963
