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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000022195
Receipt No. R000025569
Scientific Title Examination of PBRSO method for clinical models of hyperventilation syndrome
Date of disclosure of the study information 2016/05/03
Last modified on 2020/05/14

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Basic information
Public title Examination of PBRSO method for clinical models of hyperventilation syndrome
Acronym PBRSO for hyperventilation syndrome
Scientific Title Examination of PBRSO method for clinical models of hyperventilation syndrome
Scientific Title:Acronym PBRSO for hyperventilation syndrome
Region
Japan

Condition
Condition Hyperventilation syndrome
Classification by specialty
Pneumology Emergency medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm effectiveness and safety of PBRSO method for HVS.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Comparison of effectiveness by checking disappearance rate of HVS symptoms such as numbness and lightheadedness between PBR therapy using paper bag and PBRSO therapy using plastic bag for 5 minutes respectively
Key secondary outcomes Comparison of effectiveness represented by EtCO2 recovering above 30 mmHg between in PBR therapy using paper bag and in PBRSO therapy using plastic bag for 5 minutes respectively

Confirmation of safety represented by SpO2 keeping above 95% in PBR therapy using paper bag and in PBRSO therapy using plastic bag for 5 minutes respectively

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 To try 2 kinds of PBR methods after HVS
Interventions/Control_2 PBR therapy for 5 minutes
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria Healthy adults
Key exclusion criteria Cerebral vascular disease
Pulmonary dysfunction
Heart failure
Other severe disease
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Masanobu
Middle name
Last name Kishikawa
Organization Fukuoka City Hospital
Division name Department of Emergency and Critical care medicine
Zip code 812-0046
Address 13-1,Yoshizuka-honmachi, Hakata-ku, Fukuoka 812-0046, Japan
TEL 092-632-1111
Email kishikawam@aqr.bbiq.jp

Public contact
Name of contact person
1st name Masanobu
Middle name
Last name Kishikawa
Organization Fukuoka City Hospital
Division name Department of Emergency and Critical care medicine
Zip code 810-0014
Address 4-7-6,Hirao, Chuoh-ku, Fukuoka 810-0014, Japan
TEL 092-522-2846
Homepage URL http://www.fcho.jp/modules/about/
Email kishikawam@aqr.bbiq.jp

Sponsor
Institute Fukuoka City Hospital
Institute
Department

Funding Source
Organization Fukuoka City Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukuoka City Hospital
Address 4-7-6,Hirao, Chuoh-ku, Fukuoka 810-0014, Japan
Tel 09074422268
Email kishikawam@aqr.bbiq.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 福岡市立病院機構福岡市民病院

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 03 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
Date of protocol fixation
2016 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 28 Day
Last follow-up date
2016 Year 05 Month 31 Day
Date of closure to data entry
2016 Year 05 Month 31 Day
Date trial data considered complete
2016 Year 05 Month 31 Day
Date analysis concluded
2016 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 05 Month 03 Day
Last modified on
2020 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025569

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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