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

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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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046058


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name