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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033292
Receipt No. 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

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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
Institute Chiba University Hospital
Institute
Department

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
URL(English) https://upload.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


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