UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040566 |
|---|---|
| Receipt number | R000046058 |
| Scientific Title | Measurement of end tidal CO2(EtCO2) concentration during high frequency oscillatory ventilation in newborns |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/05/28 15:15:39 |
* 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
Measurement of end tidal CO2(EtCO2) concentration during high frequency oscillatory ventilation in newborns
Acronym
HFO-EtCO2
Scientific Title
Measurement of end tidal CO2(EtCO2) concentration during high frequency oscillatory ventilation in newborns
Scientific Title:Acronym
HFO-EtCO2
Region
| Japan |
Condition
Condition
Respiratory fairure of naonates
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Previously, it was difficult to measure EtCO2 during high-frequency oscillatory ventilation (HFO), but it will be verified whether or not EtCO2 in HFO can be measured by a new device of carbon dioxide monitor equipped with a sensor with a fast response speed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To verify the correlation between the value of EtCO2 by Exhaled carbon dioxide monitor and pCO2 by blood gas.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention period is during the HFO ventilation.
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
| 1 | days-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Infants who used HFO ventilation in NICU
Key exclusion criteria
none
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Sato |
Organization
Nagoya University Hospital
Division name
Centor for Maternal-Neonatal Care
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi
TEL
052-741-2111
yoshiaki@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Tanahashi |
Organization
Nagoya University Hospital
Division name
Centor for Maternal-Neonatal Care
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi
TEL
052-741-2111
Homepage URL
y.tanahashi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shizuoka Children's Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi
Tel
052-741-2111
ethics@med.nagoya-u.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 | 06 | 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
| 2020 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | 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 | 05 | Month | 28 | Day |
Last modified on
| 2020 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046058
