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
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
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
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
