UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047444 |
|---|---|
| Receipt number | R000054105 |
| Scientific Title | Expiratory airflow limitation and lung volume during high flow nasal cannula |
| Date of disclosure of the study information | 2022/04/09 |
| Last modified on | 2022/04/09 11:15:29 |
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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
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
T.Nikai@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054105
