UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015030 |
|---|---|
| Receipt number | R000017485 |
| Scientific Title | Nasal High Flow Therapy versus Non-Invasive Ventilation for ARDS: open-labeled randomized control study |
| Date of disclosure of the study information | 2014/09/08 |
| Last modified on | 2014/10/11 11:01:03 |
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Basic information
Public title
Nasal High Flow Therapy versus Non-Invasive Ventilation for ARDS: open-labeled randomized control study
Acronym
NHF vs NIV for ARDS
Scientific Title
Nasal High Flow Therapy versus Non-Invasive Ventilation for ARDS: open-labeled randomized control study
Scientific Title:Acronym
NHF vs NIV for ARDS
Region
| Japan |
Condition
Condition
ALI/ARDS based on the AECC criteria
Classification by specialty
| Pneumology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to compare Nasal high flow therapy vs. Non-invasive ventilation to improve the oxygenation of patients with ARDS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PaO2/FIO2 on NIV(CPAP 5cmH2O) vs. NHF(60L/min)
Key secondary outcomes
Trend of PaO2/FIO2
Borg scale, respiratory rate
reduction rate of endotracheal intubation
Ventilator free days in 30days
Over all survival rate, hospital day
hospital mortality
Progression Free Survival rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
NHF group: After randomisation, patients were treated with NHF (60L/min) during 30minutes and switched to NIV(CPAP 5cmH2O) during 30minutes as the crossover study. After the comparison, patients were treated with NHF(60L/min) continuously.
Interventions/Control_2
NIV group: After randomisation, patients were treated with NIV (CPAP 5cmH2O) during 30minutes and switched to NIV(60L/min) during 30minutes as the crossover study. After the comparison, patients were treated with NIV(60L/min) continuously.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) ALI/ARDS based on the AECC criteria
2) Stay in ICU or ER-ICU
3) PaO2/FIO2 300 or less on the conventional oxygen therapy
Key exclusion criteria
1) PaCO2 45Torr or more and pH 7.35 or less
2) Severe hemodynamic instabilitiy
3) PaO2/FIO2 100 or less
4) Loss of consciousness
5) Uncontrolled heart failure
6) Needed to endtracheal intubation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Taniguchi |
Organization
Tosei General Hospital
Division name
Department of Respiratory Medicine and Allergy
Zip code
Address
160 Nishi-Oiwakecho, Seto, Aichi
TEL
+81-561-82-5101
lung@tosei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiki Yokoyama |
Organization
Tosei General Hospital
Division name
Department of Respiratory Medicine and Allergy
Zip code
Address
160 Nishi-Oiwakecho, Seto, Aichi
TEL
+81-561-82-5101
Homepage URL
toshikiyokoyama1978@hotmail.co.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Allergy, Tosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
Pacific Medico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
公立陶生病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 08 | 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
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 02 | Day |
Last modified on
| 2014 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017485
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
