UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027325 |
|---|---|
| Receipt number | R000031306 |
| Scientific Title | Investigation of respiratory rate measurement by a pulse oximeter during high flow nasal cannula oxygen therapy |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2020/06/14 13:49:51 |
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Basic information
Public title
Investigation of respiratory rate measurement by a pulse oximeter during high flow nasal cannula oxygen therapy
Acronym
Investigation of respiratory rate measurement by a pulse oximeter during high flow nasal cannula oxygen therapy
Scientific Title
Investigation of respiratory rate measurement by a pulse oximeter during high flow nasal cannula oxygen therapy
Scientific Title:Acronym
Investigation of respiratory rate measurement by a pulse oximeter during high flow nasal cannula oxygen therapy
Region
| Japan |
Condition
Condition
Respiratory failure
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
PM1000N (Covidien Japan Co., Ltd.) is a pulse oximeter that continuously measures respiratory rate, but it is not sufficient to examine the accracy of respiratory rate mesurement during high flow nasal cannula oxygen therapy.
We investigate that the accracy of respiratory rate measurement using PM1000N during high flow nasal cannula oxygen therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of respiratory rate obtained by auscultation and PM 1000 N.
Key secondary outcomes
Comparison of respiratory rate obtained by ECG(thoracic impedance monitor) and PM 1000 N.
Comparison of respiratory rate obtained by Capnogram and PM 1000 N.
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
Patients in the ICU under high flow nasal cannula oxygen therapy
Key exclusion criteria
Patients who are not clear consciousness.
Patients who are poor pain control.
Patients who did not obtain consent.
Patients whom investigator judges to be inappropriate as a participant
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Gaku |
| Middle name | |
| Last name | Kawamura |
Organization
The University of Tokyo
Division name
Department of Anesthesiology, Faculty of Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
+81-3-5800-8668
Gaku-kawa@umin.ac.jp
Public contact
Name of contact person
| 1st name | Gaku |
| Middle name | |
| Last name | Kawamura |
Organization
The University of Tokyo
Division name
Department of Anesthesiology, Faculty of Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
+81-3-5800-8668
Homepage URL
Gaku-kawa@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
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
The University of Tokyo, Clinical Research Review Board
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
Tel
03-3815-5411
ethics@m.u-tokyo.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
| 2017 | Year | 05 | Month | 15 | 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
1
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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2017 | Year | 05 | Month | 12 | Day |
Last modified on
| 2020 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031306
