UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041116 |
|---|---|
| Receipt number | R000046241 |
| Scientific Title | Efficacy of nasal high flow therapy for respiratory management in patients after sagittal splitting ramus osteotomy research |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2021/01/14 13:42:38 |
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Basic information
Public title
Efficacy of nasal high flow therapy for respiratory management in patients after sagittal splitting ramus osteotomy research
Acronym
Efficacy of nasal high flow therapy for respiratory management in patients after sagittal splitting ramus osteotomy research
Scientific Title
Efficacy of nasal high flow therapy for respiratory management in patients after sagittal splitting ramus osteotomy research
Scientific Title:Acronym
Efficacy of nasal high flow therapy for respiratory management in patients after sagittal splitting ramus osteotomy research
Region
| Japan |
Condition
Condition
after sagittal splitting ramus osteotomy
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether nasal high flow therapy is more effective than conventional oxygen administration with a simple face mask in patients after sagittal splitting ramus osteotomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Continuous measurements of partial pressure of carbon dioxide and oxygen by arterial blood gas analysis and transcutaneous gas monitor from 0 hours after return to the ward to the time of waking up the next morning
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
nasal high flow therapy
Interventions/Control_2
From 0 hours after returning to the ward until waking up the next morning
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
Patients undergoing sagittal splitting ramus osteotomy for jaw deformity
Key exclusion criteria
Patients with respiratory diseases
Patients with American Society of Anesthesiologists systemic classification of 3 or higher
Patients who cannot consent to post-operative arterial line implantation and percutaneous monitoring on the ward
Patients with suspected COVID-19 infection
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Baba |
Organization
Tokyo medical and dental university graduate school of medical and dental sciences
Division name
dental anesthesiology and olofacial pain management
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358035549
yukianph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Baba |
Organization
Tokyo medical and dental university graduate school of medical and dental sciences
Division name
dental anesthesiology and olofacial pain management
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358035549
Homepage URL
yukianph@tmd.ac.jp
Sponsor or person
Institute
Tokyo medical and dental university graduate school of medical and dental sciences
dental anesthesiology and olofacial pain management
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical and dental university graduate school of medical and dental sciences
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
Ethical Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
0358035404
d-hyoka.adm@tmd.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046241
