UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045352 |
|---|---|
| Receipt number | R000051788 |
| Scientific Title | Comparison of Nasal pillow noninvasive positive pressure ventilation and high flow nasal therapy for the treatment and prevention of post extubation failure in intensive care patients |
| Date of disclosure of the study information | 2021/09/02 |
| Last modified on | 2022/09/05 19:37:03 |
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Basic information
Public title
Comparison of Nasal pillow noninvasive positive pressure ventilation and high flow nasal therapy for the treatment and prevention of post extubation failure in intensive care patients
Acronym
Comparison of Nasal pillow noninvasive positive pressure ventilation and high flow nasal therapy for the treatment and prevention of post extubation failure in intensive care patients
Scientific Title
Comparison of Nasal pillow noninvasive positive pressure ventilation and high flow nasal therapy for the treatment and prevention of post extubation failure in intensive care patients
Scientific Title:Acronym
Comparison of Nasal pillow noninvasive positive pressure ventilation and high flow nasal therapy for the treatment and prevention of post extubation failure in intensive care patients
Region
| Japan |
Condition
Condition
ICU patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the hypothesis that nasal pillow noninvasive positive pressure ventilation (NP-NPPV) has the same tolerability as high flow nasal therapy (HFNT) and higher respiratory support capacity than HFNT in patients after extubation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes were respiratory parameters (PO2/FIO2 ratio, PCO2, respiratory rate) and tolerability of each interface immediately after extubation and 24 hours later.
Key secondary outcomes
The secondary outcomes were the duration of device use, the rate of device withdrawal after 24 hours, and the incidence of skin injury associated with the interface.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent NP-NPPV or HFNT after extubation to prevent post-extubation failure after more than 24 hours of ventilatory management after surgery
Key exclusion criteria
Non-operative patients, patients who did not require ventilatory management for more than 24 hours postoperatively, patients younger than 18 years, patients who used both NP-NPPV and HFNT, tracheostomy, head and neck surgery, significant neurological disorders, patients who used NPPV or HFNT preoperatively
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Ohchi |
Organization
Oita University
Division name
Department of Anesthesiology and Intensive Care, Faculty of Medicine
Zip code
879-5593
Address
1-1 Idaigaoka, Hasamamachi, Yufu City, Oita
TEL
0975865943
ohchi-yo@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Ohchi |
Organization
Oita University
Division name
Department of Anesthesiology and Intensive Care, Faculty of Medicine
Zip code
879-5593
Address
1-1 Idaigaoka, Hasamamachi, Yufu City, Oita
TEL
0975865943
Homepage URL
http://anesth.wp.med.oita-u.ac.jp/research1/631
ohchi-yo@oita-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care, Faculty of Medicine, Oita University
Institute
Department
Personal name
Funding Source
Organization
None
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
Oita University Faculty of Medicine Ethics Committee
Address
1-1 Idaigaoka, Hasamamachi, Yufu City, Oita
Tel
097-586-6380
rinrikenkyu@oita-u.ac.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
大分大学医学部附属病院(大分県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/10.1177/03000605221112777?url_ver=Z39.88-2003&rfr_id=ori:rid:crossr
Number of participants that the trial has enrolled
110
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
| 2019 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Under the analysis of the obtained data
Management information
Registered date
| 2021 | Year | 09 | Month | 02 | Day |
Last modified on
| 2022 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051788
