UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of continuous negative pressure ventilation for acute respiratory failure in children
Title of the study (Brief title)	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	Shingo Ishimori
Organization	Kakogawa central city hospital
Division name	Department of pediatrics
Address	439, Honmachi, Kakogawa-cho, Kakogawa, Hyogo
TEL	0794515500
Email	shingo-i0324os@live.jp

Public contact
Name of contact person	Shingo Ishimori
Organization	Kakogawa central city hospital
Division name	Department of pediatrics
Address	439, Honmachi, Kakogawa-cho, Kakogawa, Hyogo
TEL	0794515500
Homepage URL
Email	shingo-i0324os@live.jp

Sponsor
Institute	Kakogawa central city hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016978