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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022020
Receipt No. 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

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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
Email 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
Email atsuko929shono@yahoo.co.jp

Sponsor
Institute Enya 89-1, Izumo city, Shimane
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
Address Enya-cho 89-1 Izumo
Tel 09094622098
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025363

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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