UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014133 |
|---|---|
| Receipt number | 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 23:05:13 |
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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
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
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
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
takeshi-su@a7.keio.jp
Sponsor or person
Institute
Kawasaki Municipal Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016417
