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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 2022/03/07

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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 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 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 Osamu
Middle name
Last name Umegaki
Organization Osaka medical college
Division name Department of intensive care unit
Zip code 5698686
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 Shiho
Middle name
Last name Deguchi
Organization Osaka medical college
Division name Department of intensive care unit
Zip code 5698686
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 Department of intensive care unit Osaka medical college
Address 2-7 Daigaku-machi, Takatsuki, Osaka
Tel 072-683-1221
Email rinri@art.osaka-med.ac.jp

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 https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019231
Publication of results Unpublished

Result
URL related to results and publications https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019231
Number of participants that the trial has enrolled 40
Results 35 patients were enrolled, and 5 patients were excluded from analysis in accordance with the exit criteria. PFR was significantly higher in the HFNC group than in the VM group [265.9 (81.4) vs. 238.7 (68.5), p=0.002]. PaCO2 was significantly lower in the HFNC group than in the VM group [33.8 (3.5) vs. 34.7 (2.9), p=0.033]. The respiratory rate was significantly lower in the HFNC group than in the VM group [18 (4) vs. 21 (4), p=0.006], and no significant differences were seen in any of the other parameters.
Results date posted
2022 Year 03 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Forty patients who underwent cardiovascular surgery
Participant flow 40 patients who underwent cardiovascular surgery in 2015 were randomized to either protocol A (HFNC followed by VM) or protocol B (VM followed by HFNC). After 60-minutes of use with either device, arterial blood gas analysis was performed, and the PaO2/FiO2 ratio (PFR) was calculated. Simultaneously, physiological data (respiratory rate, heart rate, mean arterial pressure, continuous cardiac index, and mixed venous oxygen saturation) were recorded. During this procedure, FiO2 and gas flow were maintained at a fixed rate. These variables were compared by using the paired t-test, and a p value < 0.05 was considered significant. All data were expressed as mean (standard deviation).
Adverse events Nothing
Outcome measures blood gas analysis (PaO2/FiO2 ratio (PFR) ,PaCO2, HCO3-, pH)
physiological data (respiratory rate, heart rate, mean arterial pressure, continuous cardiac index, and mixed venous oxygen saturation)
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
2014 Year 12 Month 16 Day
Anticipated trial start date
2014 Year 12 Month 16 Day
Last follow-up date
2016 Year 06 Month 30 Day
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
2022 Year 03 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019231

Research Plan
Registered date File name
2022/03/07 NHFvsVM倫理審査申請書②.doc

Research case data specifications
Registered date File name
2022/03/07 NHFvsVM説明書②.docx

Research case data
Registered date File name
2022/03/05 UMIN登録用患者背景(日本語).docx


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