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Recruitment status Completed
Unique ID issued by UMIN UMIN000014133
Receipt No. R000016417
Scientific Title Evaluation of the PEEP effect of nasal high flow compared with non-invasive positive pressure ventilation
Date of disclosure of the study information 2014/06/01
Last modified on 2018/01/13

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Basic information
Public title Evaluation of the PEEP effect of nasal high flow compared with non-invasive positive pressure ventilation
Acronym Evaluation of the PEEP effect of nasal high flow
Scientific Title Evaluation of the PEEP effect of nasal high flow compared with non-invasive positive pressure ventilation
Scientific Title:Acronym Evaluation of the PEEP effect of nasal high flow
Region
Japan

Condition
Condition Patients receiving non-invasive positive pressure ventilation for respiratory failure
Classification by specialty
Medicine in general Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the PEEP effect of nasal high flow (NHF) as compared with non-invasive positive pressure ventilation (NPPV) through evaluation of respiratory parameters including blood gas analysis after weaning from NPPV to NHF
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of partial pressure of arterial oxygen tension to inspiratory oxygen fraction ratio and respiratory ratio between NHF and NPPV
Key secondary outcomes The rate of rescue NIV therapy and intubation, the frequency of respiratory failure, the duration of NHF therapy, the length of ICU stay after weaning from NIV, and acceptability of NHF therapy compared with NIV

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Among patients under management of NPPV for more than 24 hours, those who meet the following criteria at the 5cmH2O PEEP level; 1) 300 > P/F ratio > 200 2) 15 < respiratory rate < 30/min
Key exclusion criteria Patients younger than 18 years old or with Glasgow Coma Scale less than 14 or with body mass index (BMI) more than 30
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Kurazumi
Organization Kawasaki Municipal Hospital
Division name Anesthesiology
Zip code
Address 12-1 Shinkawadori, Kawasaki-ku, Kawasaki-shi, Kanagawa 210-0013 Japan
TEL 044-233-5521
Email takfromnarita@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Suzuki
Organization Keio University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email takeshi-su@a7.keio.jp

Sponsor
Institute Kawasaki Municipal Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Kawasaki Municipal Hospital
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2012 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In patients who met the weaning criteria, the respiratory setting of NPPV was changed to continuous positive airway pressure (CPAP) mode with PEEP of 4 cmH2O and FIO2 equal to or less than 0.5. Blood gas analysis and evaluation of respiratory rate were performed one hour after changing the respiratory setting. Thereafter, NIV was interrupted and humidified high-flow oxygen via NHF system was delivered through a wide-bore nasal cannula at the following setting; gas flow 50 l/min and FIO2 equal to or less than 0.5. One hour after the application of NHF, blood gas analysis and evaluation of respiratory rate were performed, and compared with those during NPPV management. In the historical control group who were weaned from NPPV to oxygen mask, the same evaluation of respiratory parameters was performed.

Management information
Registered date
2014 Year 05 Month 31 Day
Last modified on
2018 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016417


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