UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022020 |
|---|---|
| Receipt number | R000025363 |
| Scientific Title | The effect of High Flow Nasal Cannula (HFNC) on end-expiratory lung volume in acute lung injury patients |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/11/03 17:39:55 |
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Basic information
Public title
The effect of High Flow Nasal Cannula (HFNC) on end-expiratory lung volume in acute lung injury patients
Acronym
Lung volume during HFNC
Scientific Title
The effect of High Flow Nasal Cannula (HFNC) on end-expiratory lung volume in acute lung injury patients
Scientific Title:Acronym
Lung volume during HFNC
Region
| Japan |
Condition
Condition
patients with acute lung injury
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of high flow nasal oxygen therapy on lung volume in the patients with acute lung injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
increase in end-expiratory lung volume during HFNC (high flow nasal canula)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Aplly HFNC to the patients with ALI and monitor lung volume by EIT (Electrical impedance tomograpy)for 24 hours during HFNC
Evaluate the changes in lung volume with different flow rates of HFNC (10,20,30,40,50L/min)
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)ALI (Respiratory rate >25/min, SpO2 <96%)
2)Impaired oxygenation with P/F ratio <300mmHg
3)Within 48 hours since diagnose of ALI
4)Written informed consent
Key exclusion criteria
1)Impaired lung function (COPD grade > 3, or FEV1s < 1000ml)
2)Severly impaired oxgenation with P/F ratio <150mmHg
3)Chronic heart failure (Cardiac index < 1.8L/m2, NYHA > or = 3 )
4)Unstable hemodynamics (mean arterial pressure < 50mmHg)
5)Glasgow Coma Scale <8
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Shono |
Organization
Shimane University
Division name
Department of Anesthesiology, Faculty of medicine
Zip code
6938501
Address
Enya 89-1, Izumo city, Shimane
TEL
09094622098
atsuko929shono@yahoo.co.jp
Public contact
Name of contact person
| 1st name | atsuko |
| Middle name | |
| Last name | shono |
Organization
Shimane University
Division name
Department of Anesthesiology, Faculty of medicine
Zip code
6938501
Address
Enya 89-1, Izumo city, Shimane
TEL
09094622098
Homepage URL
atsuko929shono@yahoo.co.jp
Sponsor or person
Institute
Enya 89-1, Izumo city, Shimane
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
Address
Enya-cho 89-1 Izumo
Tel
09094622098
atsuko929shono@yahoo.co.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
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
4
Results
no effect of flow rate on EELV
Results date posted
| 2019 | Year | 11 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
acute lung injury patinets
Participant flow
ALI patients included in the study
Adverse events
none
Outcome measures
no effect of flow rate on EELV
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 21 | Day |
Last modified on
| 2019 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025363
