UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025861
Receipt No. R000029737
Scientific Title Effect of noninvasive ventilation with RAM cannula and ICU ventilator equipped with leak compensation algorithm
Date of disclosure of the study information 2017/03/01
Last modified on 2018/07/29

* 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 Effect of noninvasive ventilation with RAM cannula and ICU ventilator equipped with leak compensation algorithm
Acronym Pediatric noninvasive ventilation with RAM cannula
Scientific Title Effect of noninvasive ventilation with RAM cannula and ICU ventilator equipped with leak compensation algorithm
Scientific Title:Acronym Pediatric noninvasive ventilation with RAM cannula
Region
Japan

Condition
Condition acute respiratory failure
Classification by specialty
Pneumology Surgery in general Pediatrics
Cardiovascular surgery Emergency medicine Intensive care medicine
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of pediatric noninvasive ventilation with RAM cannula and ICU ventilator.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes thoracoabdominal synchrony, respiratory rate, arterial blood gas analyses
Key secondary outcomes Therapy tolerance, complication of the use of RAM cannula

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients will take noninvasive ventilation with RAM cannula and ICU ventilator for 120 min after 20-min conventional oxygen therapy.
Interventions/Control_2 Patients will take conventional oxygen therapy for 20 min.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients weighing 2-8 kg and acutely suffering from respiratory distress after tracheal extubation.
Key exclusion criteria Patients with severe circulatory and respiratory failure, facial trauma, nasal congestion, incorporation to the therapy and Glasgow coma scale less than 12.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taiga Itagaki
Organization Tokushima University Graduate School
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 3-18-15 Kuramotocho, Tokushima 7708503, Japan
TEL +81-88-633-9347
Email taiga@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taiga Itagaki
Organization Tokushima University Graduate School
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 3-18-15 Kuramotocho, Tokushima 7708503, Japan
TEL +81-88-633-9347
Homepage URL
Email taiga@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization None
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
2017 Year 03 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
Study terminated
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 Terminated
Date of protocol fixation
2017 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2018 Year 06 Month 29 Day
Date of closure to data entry
2018 Year 06 Month 29 Day
Date trial data considered complete
2018 Year 06 Month 29 Day
Date analysis concluded
2018 Year 06 Month 29 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 26 Day
Last modified on
2018 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029737

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.