UMIN-CTR Clinical Trial

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
Email	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
Email	y.tanahashi@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046058