UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022195
Receipt number 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 2020/11/12 01:37:39

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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 or person

Institute

Fukuoka City Hospital

Institute

Department

Personal name



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

Value
https://center6.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