UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of high-flow nasal cannula therapy among patients undergoing cardiothoracic surgery
Title of the study (Brief title)	high-flow nasal cannula therapy in patients undergoing cardiothoracic surgery
Region	Japan

Condition
Condition	Patients undergoing cardiothoracic surgery
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the beneficial effects of high-flow oxygen cannula therapy among patients undergoing cardiothracic surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Days under high-flow oxygen cannula therapy
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All the patients that used high-flow nasal cannula therapy after cardiothoracic surgery
Key exclusion criteria	None
Target sample size	150

Research contact person
Name of lead principal investigator	Kiyoshi Moriyama
Organization	Kyorin University School of Medicine
Division name	Department of Anesthesiology
Address	6-20-2 Shinkawa, Mitaka, Tokyo 181-8611
TEL	0422-47-5511
Email	mokiyo@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Kiyoshi Moriyama
Organization	Kyorin University School of Medicine
Division name	Department of Anesthesiology
Address	6-20-2 Shinkawa, Mitaka, Tokyo 181-8611
TEL	0422-47-5511
Homepage URL
Email	mokiyo@ks.kyorin-u.ac.jp

Sponsor
Institute	Department of Anesthesiology, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Kyorin University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 07 Month 29 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 07 Month 15 Day
Anticipated trial start date	2016 Year 07 Month 29 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	observational study

Management information
Registered date	2016 Year 07 Month 28 Day
Last modified on	2019 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026940