UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030299 |
|---|---|
| Receipt number | R000034483 |
| Scientific Title | The compatibility of noninvasive respiratory rate measurement by Nellcor TM PM1000N in pediatric patients |
| Date of disclosure of the study information | 2017/12/07 |
| Last modified on | 2018/06/12 13:59:35 |
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Basic information
Public title
The compatibility of noninvasive respiratory rate measurement by Nellcor TM PM1000N in pediatric patients
Acronym
Respiratory rate measurement by PM1000N in pediatric patients
Scientific Title
The compatibility of noninvasive respiratory rate measurement by Nellcor TM PM1000N in pediatric patients
Scientific Title:Acronym
Respiratory rate measurement by PM1000N in pediatric patients
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the compatibility of respiratory rate measurement by pulse oximeter-based photoplethysmogram using Nellcor TM PM 1000N with other means in pediatric patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bias, Limit of agreement (LOA) and relative error by Bland-Altman analysis of respiratory rate from pulse oximeter-based photoplethysmogram, ECG-based trans-thoracic impedance system and manual assessment
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Postoperative, non-iutubated pediatric patients
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Izumi |
Organization
Fukuoka Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
Kashii-Teriha 5-1-1, Higashi-ku, Fukuoka city
TEL
092-982-7000
izumi.k@fcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoru Izumi |
Organization
Fukuoka Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
Kashii-Teriha 5-1-1, Higashi-ku, Fukuoka city
TEL
092-682-7000
Homepage URL
izumi.k@fcho.jp
Sponsor or person
Institute
Department of Anesthesiology, Fukuoka Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Children's Hosipital
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
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
福岡市立こども病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 10 | Day |
Other
Other related information
Mesurement of respiratory rate by pulse oximeter-based photoplethysmogram, ECG-based trans-thoracic impedance system and manual assessment
Management information
Registered date
| 2017 | Year | 12 | Month | 07 | Day |
Last modified on
| 2018 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034483
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/06/08 | 対象と方法.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/06/08 | 症例.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/06/08 | 結果.docx |
