UMIN-CTR Clinical Trial

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	12
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	on going to analyze data
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	2016 Year 04 Month 26 Day
Date of IRB	2016 Year 05 Month 31 Day
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 11 Month 12 Day

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