UMIN-CTR Clinical Trial

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
Email	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
Email	Gaku-kawa@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031306