UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	High flow nasal cannula versus venturi mask for cardiovascular surgical patients after endotracheal extubation: A randomized crossover study
Title of the study (Brief title)	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	Osamu Umegaki
Organization	Osaka medical College
Division name	Department of intensive care medicine
Address	2-7 Daigaku-machi, Takatsuki, Osaka
TEL	+81-72-683-1221
Email	Y.kusaka1978@gmail.com

Public contact
Name of contact person	Yusuke Kusaka
Organization	Osaka medical College
Division name	Department of intensive care medicine
Address	2-7 Daigaku-machi, Takatsuki, Osaka
TEL	+81-72-683-1221
Homepage URL
Email	Y.kusaka1978@gmail.com

Sponsor
Institute	Department of intensive care medicine, Osaka medical college
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016566