UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033980
Receipt number R000038623
Scientific Title Effect of mechanical sputum assistance for ventilated patients in intensive care unit
Date of disclosure of the study information 2018/09/01
Last modified on 2020/05/25 22:20:07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of mechanical sputum assistance for ventilated patients in intensive care unit

Acronym

Effect of mechanical sputum assistance for ventilated patients in intensive care unit

Scientific Title

Effect of mechanical sputum assistance for ventilated patients in intensive care unit

Scientific Title:Acronym

Effect of mechanical sputum assistance for ventilated patients in intensive care unit

Region

Japan


Condition

Condition

Ventilated patients in the intensive care unit

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effectiveness of Mechanical Insufflator-Exsufflator (MI-E) for ventilated patients in the intensive care unit.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Number of ventilatorv days
Number of ICU days

Key secondary outcomes

rate of reintubatiorn
rate of tracheotomy


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Use MI-E for 10 times at 40 cmH2O for ventilated patietns

Interventions/Control_2

ICU patients who received standard care only

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

ICU patients who required ventilation for at least 24h and expected for 48h
ICU patients who require lung physical therapy for exsufflation of sputum

Key exclusion criteria

Patients whom principal investigators judge to be inappropriate for examinee.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kensuke Nakamura

Organization

Hitachi General Hospital

Division name

Department of emergency andi intensive care medicine

Zip code


Address

2-1-1, Jonancho, Hitachi city, Ibaraki prefecture

TEL

0294-23-1111

Email

kensuke.nakamura.oz@hitachi.com


Public contact

Name of contact person

1st name
Middle name
Last name Kensuke Nakamura

Organization

Hittachi Gerneral Hospital

Division name

Department of emergency and intensive care medicine

Zip code


Address

2-1-1, Jonancho, Hitachi city, Ibaraki prefecture

TEL

0294-23-1111

Homepage URL


Email

kensuke.nakamura.oz@hitachi.com


Sponsor or person

Institute

Hittachi Gerneral Hospital

Institute

Department

Personal name



Funding Source

Organization

Hittachi Gerneral Hospital

Organization

Division

Category of Funding Organization

Other

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

2018 Year 09 Month 01 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

38

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

2017 Year 11 Month 14 Day

Date of IRB

2017 Year 09 Month 13 Day

Anticipated trial start date

2017 Year 11 Month 14 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 01 Day

Last modified on

2020 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038623


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name