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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015030
Receipt No. 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

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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
Email 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
Email toshikiyokoyama1978@hotmail.co.jp

Sponsor
Institute Department of Respiratory Medicine and Allergy, Tosei General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017485

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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