UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015885 |
|---|---|
| Receipt number | R000017749 |
| Scientific Title | A study to evaluate usefulness of biphasic extrathoracic cuirass ventilation (BCV) for acute respiratory failure in infants: A multicenter randomized controlled test with standard treatment as the control. |
| Date of disclosure of the study information | 2014/12/10 |
| Last modified on | 2017/10/07 06:13:36 |
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Basic information
Public title
A study to evaluate usefulness of biphasic extrathoracic cuirass ventilation (BCV) for acute respiratory failure in infants: A multicenter randomized controlled test with standard treatment as the control.
Acronym
RCT of BCV for acute respiratory failure in infants
Scientific Title
A study to evaluate usefulness of biphasic extrathoracic cuirass ventilation (BCV) for acute respiratory failure in infants: A multicenter randomized controlled test with standard treatment as the control.
Scientific Title:Acronym
RCT of BCV for acute respiratory failure in infants
Region
| Japan |
Condition
Condition
respiratory tract infection
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We wanted to investigate the effect of BCV for respiratory distress in infants by comparing with standard treatment as a control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of infants who required additional treatments, including mechanical ventilation (CMV, NPPV and BCV) due to respiratory distress induring 24 hours after treatent.
Key secondary outcomes
Blood gas analysis at 1 hour after treatment.
VAS(Visual analogue scale)1 hour after treatment.
mPIS at 1,2 and 3 hours after treatment.
mPIS at 24 hours after treatment.
mPIS when BCV could be discontinued because of an improvement of symptoms.
mPIS when the management by positive pressure ventilation was started because of worsening of symptoms.
The frequency of additional treatments due to worsening of symptoms during the periods from the entrance to the end of the trial.
Validity of of the timing to discontinue BCV.
The number of infants BCV was restarted because of wosening of symptoms.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Biphasic cuirass ventiration
Interventions/Control_2
Control treatment
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
| 2 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The criteria of subjects in the present study were as following;
Less than 2 years old
sPO2 level was between the value of 90% or more and less than 95%.
Those who were diagnosed as respiratory diseases including bronchitis, pneumonia, bronchiolitis and so on.
A written consent was obtained from the guardian.
Key exclusion criteria
Children requiring intratracheal intubation or mechanical ventilation (CMV: Conventional NPPV: Non-invasive Positive Pressure Ventilation) on admission.
Children whose symptoms have been diagnosed as acute asthma attack.
Children with circulatory failure.
Children with primary disease (cyanotic heart disease, chronic lung disease, upper airway disease, thoracic deformity, cerebral palsy, congenital metabolic disorder).
Severely multiple handicapped children.
Children who were estimated not to be suitable for the study subjects by the attending physician.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Ueda |
Organization
Saitama Medical University Hospital
Division name
Pediatrics
Zip code
Address
Saitama prf. iruma-gun moroyama-machi morohongo38
TEL
049-276-1218
y_ueda@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Ueda |
Organization
Saitama Medical University Hospital
Division name
Pediatrics
Zip code
Address
Saitama prf. iruma-gun moroyama-machi morohongo38
TEL
049-276-1218
Homepage URL
y_ueda@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Kawano masanoriMedical Public Internet Incorprated Fundation for Promotion of Pediatrics.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
埼玉医科大学病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 10 | 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 | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 19 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 09 | Day |
Last modified on
| 2017 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017749
