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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006326
Receipt No. R000007501
Scientific Title Respiratory characteristics during control ventilation and spontaneous breathing trial in patients with mechanical ventilation
Date of disclosure of the study information 2011/09/15
Last modified on 2012/07/03

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Basic information
Public title Respiratory characteristics during control ventilation and spontaneous breathing trial in patients with mechanical ventilation
Acronym Respiratory characteristics during control ventilation and spontaneous breathing trial in patients with mechanical ventilation
Scientific Title Respiratory characteristics during control ventilation and spontaneous breathing trial in patients with mechanical ventilation
Scientific Title:Acronym Respiratory characteristics during control ventilation and spontaneous breathing trial in patients with mechanical ventilation
Region
Japan

Condition
Condition Patients received mechanical ventilation in ICU
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examined tracheal pressure in the expiratory phase and imposed expiratory work of brathing by the endotrachal tube and the ventilator in ICU patients received mechanical ventilation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes We hypothesized that imposed patients respiratory load in expiratory phase by an endotrachal tube and a ventilator would be increased in case of increased ventilatory demand.
Key secondary outcomes

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
15 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patient received mechanical ventilation more than 48 hr
Key exclusion criteria Patients with tracheostomy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akinori Uchiyama
Organization Osaka University Hospital
Division name Intensive care unit
Zip code
Address 2-15Yamadaoka Suita
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Hospital
Division name Intensive care unit
Zip code
Address
TEL 81-6-6879-5824
Homepage URL
Email

Sponsor
Institute ICU Osaka Unversity Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2011 Year 09 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
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
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information Patients receiving mechanical ventilation were studied in an ICU. We measured airway pressure and respiratory flow during assist control mode (A/C) or during SBT which was performed in CPAP + pressure support ventilation mode.

Management information
Registered date
2011 Year 09 Month 11 Day
Last modified on
2012 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007501

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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