UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014593
Receipt number R000016978
Scientific Title The study of continuous negative pressure ventilation for acute respiratory failure in children
Date of disclosure of the study information 2014/07/18
Last modified on 2017/08/14 15:55:47

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Basic information

Public title

The study of continuous negative pressure ventilation for acute respiratory failure in children

Acronym

The study of continuous negative pressure ventilation for acute respiratory failure in children

Scientific Title

The study of continuous negative pressure ventilation for acute respiratory failure in children

Scientific Title:Acronym

The study of continuous negative pressure ventilation for acute respiratory failure in children

Region

Japan


Condition

Condition

Acute respiratory failure in children

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Avoidance of tracheal intubation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of tracheal intubation

Key secondary outcomes

Duration of admission, mechanichal ventilation, and rate of re-imprementation of mechanichal ventilation


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Continuous negative pressure ventilation using biphasic cuirass 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

0 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with forced breathing maneuver in pediatric acute respiratory disease

Key exclusion criteria

Patients with pneumothorax, upper airway narrowing, congenital central hypoventilation syndrome, and patients who had chest operation.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shingo Ishimori

Organization

Kakogawa central city hospital

Division name

Department of pediatrics

Zip code


Address

439, Honmachi, Kakogawa-cho, Kakogawa, Hyogo

TEL

0794515500

Email

shingo-i0324os@live.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shingo Ishimori

Organization

Kakogawa central city hospital

Division name

Department of pediatrics

Zip code


Address

439, Honmachi, Kakogawa-cho, Kakogawa, Hyogo

TEL

0794515500

Homepage URL


Email

shingo-i0324os@live.jp


Sponsor or person

Institute

Kakogawa central city hospital

Institute

Department

Personal name



Funding Source

Organization

Kakogawa central city hospital

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

2014 Year 07 Month 18 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

Completed

Date of protocol fixation

2014 Year 07 Month 02 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 07 Month 18 Day

Last modified on

2017 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016978


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name