UMIN-CTR Clinical Trial

Basic information
Public title	Expiratory airflow limitation and lung volume during high flow nasal cannula
Acronym	Airflow limitation during HFNC
Scientific Title	Expiratory airflow limitation and lung volume during high flow nasal cannula
Scientific Title:Acronym	Airflow limitation during HFNC
Region	Japan

Condition
Condition	hypoxemia in intensive care unit
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to investigate the effect of high flow nasal cannula on expiratory airflow limitation and lung volume
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Expiratory airflow limitation during high flow nasal cannula
Key secondary outcomes	Lung volume blood gas analysis

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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)hypoxemia with P/F ratio<300mmHg requiring high flow nasal cannula oxygen therapy 2)age 20<=, <=80 3)admission on ICU 4)written informed consent
Key exclusion criteria	1) sever obstructive respiratory failure (COPD grade>3, or FEV1s<1000ml) 2) sever heart failure (New York Heart Association grade=>3) 3) hemodynamic instability with mean blood pressure <=60mmHg 4) loss of consciousness
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tetsuro Middle name Last name Nikai
Organization	Shimane university hospital
Division name	Intensive care medicine
Zip code	693-8501
Address	Enya 89-1, Izumo, Shimane, Japan
TEL	0853-20-2295
Email	T.Nikai@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Tetsuro Middle name Last name Nikai
Organization	Shimane university hospital
Division name	Intensive care medicine
Zip code	693-8501
Address	Enya 89-1, Izumo, Shimane, Japan
TEL	0853-20-2295
Homepage URL
Email	T.Nikai@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	None
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	Shimane University Hospital, Clinical Trial Review Board
Address	89-1, Enya, Izumo, Shimane, Japan
Tel	0853-20-2515
Email	kenkyu@med.shimane-u.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	2022 Year 04 Month 09 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	2020 Year 02 Month 18 Day
Date of IRB	2020 Year 02 Month 18 Day
Anticipated trial start date	2020 Year 02 Month 18 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	monitor the time of expiration and lung volume during high flow nasal cannula using electrical impedance tomography in patients with hypoxia

Management information
Registered date	2022 Year 04 Month 09 Day
Last modified on	2022 Year 04 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054105