UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033292
Receipt number R000037926
Scientific Title Mechanical In-Exsufflation for the prevention of ventilator-associated pneumonia in ICU : A Retrospective cohort study
Date of disclosure of the study information 2018/07/15
Last modified on 2019/07/09 06:07:27

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Basic information

Public title

Mechanical In-Exsufflation for the prevention of ventilator-associated pneumonia in ICU : A Retrospective cohort study

Acronym

Mechanical In-Exsufflation for the prevention of ventilator-associated pneumonia in ICU

Scientific Title

Mechanical In-Exsufflation for the prevention of ventilator-associated pneumonia in ICU : A Retrospective cohort study

Scientific Title:Acronym

Mechanical In-Exsufflation for the prevention of ventilator-associated pneumonia in ICU

Region

Japan


Condition

Condition

critically ill patients

Classification by specialty

Intensive care medicine Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to assess the efficacy of MI-E in preventing VAP for critically ill patients in ICU field.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome of our study is incidence of VAP, defined as pneumonia developing in a person who has been on mechanical ventilation (MV) for at least 48 hours and in term of MV.

Key secondary outcomes

Infection-related Ventilator-Associated Complication (IVAC), the duration of MV, length of stay in ICU, mortality, the number of VAP/MV duration, Max clinical pulmonary infection score, bronchoscopy, bronchoscopy/MV duration,the event of bronchial obstruction (the event was oxyhemoglobin saturations of < 90%), the event of bronchial obstruction/duration of MV. antibiotic use day (with suspected VAP), antibiotic use day/duration of MV


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

7 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients was recived mechanical ventilation for at least 48 h and rehabilitation in general ICU between January 2014 and September 2017.

Key exclusion criteria

1) Aspiration or community-acquired pneumonia, provision of mechanical ventilation for < 48 h
2) Pneumothorax and pneumomediastinum, chronic obstructive pulmonary disease with bulla
3) Severe cardiovascular failure
4) Active alveolar hemorrhage
5) The patients had sustained any injury or developed any complication
6) Patients younger than 7 years
7) Patients were received rehabilitation less than 5 days

Target sample size

800


Research contact person

Name of lead principal investigator

1st name Astushi
Middle name
Last name Murata

Organization

Chiba University Hospital

Division name

Division of Rehabilitation Medicine

Zip code

260-8677

Address

1-8-1 Inohana Chuo-ku, Chiba city

TEL

043-222-7171

Email

atsushi_murata@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Ryota
Middle name
Last name Kuroiwa

Organization

Chiba University Hospital

Division name

Division of Rehabilitation Medicine

Zip code

260-8677

Address

1-8-1 Inohana Chuo-ku, Chiba city

TEL

043-222-7171

Homepage URL


Email

pseudoarthrosis7@chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

No funding source

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

Independent Ethics Committee of Graduate School of Medicine and School of Medicine, Chiba University

Address

1-8-1 Inohana Chuo-ku, Chiba city

Tel

043-226-2501

Email

igaku-kouhou@chiba-u.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



Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 15 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

689

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

2018 Year 05 Month 07 Day

Date of IRB

2018 Year 06 Month 19 Day

Anticipated trial start date

2018 Year 06 Month 20 Day

Last follow-up date

2019 Year 04 Month 18 Day

Date of closure to data entry

2019 Year 04 Month 18 Day

Date trial data considered complete

2019 Year 04 Month 18 Day

Date analysis concluded



Other

Other related information

Outcome measured
The following clinical information is obtained.
1) Infection-related Ventilator-Associated Complication (IVAC)
2) Possible VAP (PVAP)
3) Max CPIS
4) bronchoscopy
5) bronchoscopy/MV duration
6) the event of bronchial obstruction (the event was oxyhemoglobin saturations of < 90%)
7) the event of bronchial obstruction/duration of MV
8) antibiotic use day (with suspected VAP)
9) antibiotic use day/duration of MV
10) the duration of MV
11) length of stay in ICU
12) mortality
13) the number of VAP/MV duration
14) adverse effect of MI-E
15) APACHE II (acute physiology and chronic health evaluation)
16) SOFA (sequential organ failure assessment)
17) GCS (glasgow coma scale)
18) PaO2/FiO2 ratio
Other data recorded included demographic information, age, BMI, the kind of diagnosis


Management information

Registered date

2018 Year 07 Month 05 Day

Last modified on

2019 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037926


Research Plan
Registered date File name
2018/07/05 3089計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/04/18 Dataset for UMIN.xlsx