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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028285
Receipt No. R000032384
Scientific Title Multidisciplinary Approach by Respiratory Care Support Team for Patients Receiving Prolonged Mechanical Ventilation
Date of disclosure of the study information 2017/07/19
Last modified on 2017/07/19

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Basic information
Public title Multidisciplinary Approach by Respiratory Care Support Team for Patients Receiving Prolonged Mechanical Ventilation
Acronym Multidisciplinary Approach by Respiratory Care Support Team
Scientific Title Multidisciplinary Approach by Respiratory Care Support Team for Patients Receiving Prolonged Mechanical Ventilation
Scientific Title:Acronym Multidisciplinary Approach by Respiratory Care Support Team
Region
Japan

Condition
Condition tracheostomized patients undergoing prolonged mechanical ventilation
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this prospective cohort study was to evaluate a multidisciplinary approach to ventilator weaning by a dedicated professional respiratory support team in tracheostomized patients undergoing prolonged mechanical ventilation.
Basic objectives2 Others
Basic objectives -Others The purpose of this prospective cohort study was to evaluate a multidisciplinary approach to ventilator weaning by a dedicated professional respiratory support team in tracheostomized patients undergoing prolonged mechanical ventilation.
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome was the proportion of patients who could be completely liberated from ventilation, i.e., for 24 hours per day.
Key secondary outcomes The secondary outcome was the proportion of patients who could be temporarily weaned, i.e., for more than 8 hours per day. The condition of the tracheostomy and the patient`s overall health status at the time of discharge from hospital were also assessed.

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
20 years-old <
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria The study participants were tracheostomized patients who had received prolonged mechanical ventilation in the intensive care unit (ICU) and were then transferred to a general ward.
Key exclusion criteria Best support care
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Hirasawa
Organization Tosei General Hospital
Division name Department of Rehabilitation
Zip code
Address 160 Nishioiwake-cho, Seto, Aichi 489-8642, Japan
TEL 0561-82-5101
Email heijunjun@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Arizono
Organization Seirei Christopher University,
Division name School of Health Sciences
Zip code
Address 3453 Mikataha Kitaku, Hamamatsu, Shizuoka
TEL 053-439-1400
Homepage URL
Email arizono-s@umin.ac.jp

Sponsor
Institute Seirei Christopher University
Institute
Department

Funding Source
Organization no
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
2017 Year 07 Month 19 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
Thirty-six (90%) of the 40 patients were successfully liberated from mechanical ventilation after a mean ventilated duration of 92.2 days.
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
2008 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information Of the remaining four patients, two were liberated from mechanical ventilation for 8 hours per day and the other two were deemed to be permanently ventilator-dependent. Of the 36 patients who were successfully weaned, 17 were discharged to home without care, four were discharged to home with care, and 13 were discharged to a nursing home. No serious problems were encountered by the RST when weaning patients from mechanical ventilation.

Management information
Registered date
2017 Year 07 Month 19 Day
Last modified on
2017 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032384

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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