UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027325
Receipt No. 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 2018/04/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Gaku Kawamura
Organization The University of Tokyo
Division name Department of Anesthesiology, Faculty of Medicine
Zip code
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
Middle name
Last name Gaku Kawamura
Organization The University of Tokyo
Division name Department of Anesthesiology, Faculty of Medicine
Zip code
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
Address
Tel
Email

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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
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
2018 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031306

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.