UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014241 |
|---|---|
| Receipt number | R000016566 |
| Scientific Title | High flow nasal cannula versus venturi mask for cardiovascular surgical patients after endotracheal extubation: A randomized crossover study |
| Date of disclosure of the study information | 2014/06/11 |
| Last modified on | 2017/01/10 22:14:19 |
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Basic information
Public title
High flow nasal cannula versus venturi mask for cardiovascular surgical patients after endotracheal extubation: A randomized crossover study
Acronym
High flow nasal cannula versus venturi mask for cardiovascular surgical patients after endotracheal extubation.
Scientific Title
High flow nasal cannula versus venturi mask for cardiovascular surgical patients after endotracheal extubation: A randomized crossover study
Scientific Title:Acronym
High flow nasal cannula versus venturi mask for cardiovascular surgical patients after endotracheal extubation.
Region
| Japan |
Condition
Condition
Patient who underwent cardiovascular surgery
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate efficacy of high flow nasal cannula for cardiovascular surgical patients after extubation compared with venturi mask.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Arterial blood gas analysis (PaO2,PaCO2,pH,HCO3-)
Key secondary outcomes
Physiologic data (respiratory rate, heart rate, blood pressure, cardiac index, mixed venous oxygen saturation), and patient comfort.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Protocol A (venturi mask for an hour followed by high flow nasal cannula for an hour)
Interventions/Control_2
Protocol B (high flow nasal cannula for an hour followed by venturi mask for an hour)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient scheduled cardiovascular surgery (valvular surgery and coronary artery bypass grafting with median sternotomy using cardiopulmonary bypass.
Key exclusion criteria
Patient who has chronic obstructive lung disease and chronic renal failure.
Patient who requires more than 24 hours until extubation.
Emergent surgery.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Umegaki |
Organization
Osaka medical College
Division name
Department of intensive care medicine
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
+81-72-683-1221
Y.kusaka1978@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Kusaka |
Organization
Osaka medical College
Division name
Department of intensive care medicine
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
+81-72-683-1221
Homepage URL
Y.kusaka1978@gmail.com
Sponsor or person
Institute
Department of intensive care medicine, Osaka medical college
Institute
Department
Personal name
Funding Source
Organization
Department of intensive care medicine, Osaka medical college
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 11 | 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
| 2014 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 11 | 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
| 2014 | Year | 06 | Month | 12 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016566
