UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018117
Receipt number R000020975
Scientific Title Effect of feedback by NIRO-CCR1 during cardiopulmonary resuscitation for patients with out-of-hospital cardiac arrest
Date of disclosure of the study information 2015/06/28
Last modified on 2016/06/30 13:34:41

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Basic information

Public title

Effect of feedback by NIRO-CCR1 during cardiopulmonary resuscitation for patients with out-of-hospital cardiac arrest

Acronym

Effect of feedback by NIRO-CCR1 during CPR for OHCA patients

Scientific Title

Effect of feedback by NIRO-CCR1 during cardiopulmonary resuscitation for patients with out-of-hospital cardiac arrest

Scientific Title:Acronym

Effect of feedback by NIRO-CCR1 during CPR for OHCA patients

Region

Japan


Condition

Condition

out-of-hospital cardiac arrest

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the quality of CPR by emergency medical services and the effects of feedback by NIRO-CCR1 during cardiopulmonary resuscitation for patients with out-of-hospital cardiac arrest

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Rate of return of spontaneous circulation

Key secondary outcomes

Survival rate
Rate of favorable neurological outcome
Relationships between parameters of NIRO-CCR1 and outcomes


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Monitoring by NIRO-CCR1 during cardiopulmonary resuscitation by emergency medical services

Interventions/Control_2

No monitoring by NIRO-CCR1 during cardiopulmonary resuscitation by emergency medical services

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

OHCA patients performed CPR by emergency medical services in Sapporo

Key exclusion criteria

OHCA by trauma

Target sample size

700


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mineji Hayakawa

Organization

Hokkaido University Hospital

Division name

Emergency and Critical Care Center

Zip code


Address

N14W5, kita-Ku, Sapporo, 060-8648, Japan

TEL

011-706-7377

Email

mineji@dream.com


Public contact

Name of contact person

1st name
Middle name
Last name Mineji Hayakawa

Organization

Hokkaido University Hospital

Division name

Emergency and Critical Care Center

Zip code


Address

N14W5, kita-Ku, Sapporo, 060-8648, Japan

TEL

011-706-7377

Homepage URL


Email

mineji@dream.com


Sponsor or person

Institute

Sapporo city fire department

Institute

Department

Personal name



Funding Source

Organization

Foundation for
Ambulance Service Development in Japan.

Organization

Division

Category of Funding Organization

Non profit foundation

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

2015 Year 06 Month 28 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

2015 Year 06 Month 23 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 06 Month 28 Day

Last modified on

2016 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name