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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016572
Receipt No. R000019231
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 2015/02/18
Last modified on 2015/02/18

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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 Patients 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 date(respiratory rate, heart rate, blood pressure, cardiac index, mixed venous oxygen saturation)

Base
Study type

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 30 minutes, venturi mask for one hour,high flow nasal cannula for one hour
Interventions/Control_2 Protocol B
venturi mask for 30 minutes,high flow nasal cannula for one hour,venturi mask for one 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 Patients scheduled cardiovascular surgery (valvuar surgery and coronary artery bypass grafting with median sternotomy using cardiopulmonary bypass)
Key exclusion criteria Patients who has obstructive lung disease and chronic renal failure.
Patients who requires more than 24 hours until extubation.
Emergent surgery
Target sample size 40

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 unit
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka
TEL +81-72-683-1221
Email swithp2006@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiho Deguchi
Organization Osaka medical college
Division name Department of intensive care unit
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka
TEL +81-72-683-1221
Homepage URL
Email swithp2006@yahoo.co.jp

Sponsor
Institute Department of intensive care unit
Osaka medical college
Institute
Department

Funding Source
Organization Department of intensive care unit
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
Email

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
2015 Year 02 Month 18 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 Open public recruiting
Date of protocol fixation
2014 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 16 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
2015 Year 02 Month 18 Day
Last modified on
2015 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019231

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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