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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033022
Receipt No. R000037645
Scientific Title Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure
Date of disclosure of the study information 2018/06/20
Last modified on 2018/06/16

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Basic information
Public title Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure
Acronym Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure
Scientific Title Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure
Scientific Title:Acronym Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure
Region
Japan

Condition
Condition Acute respiratory failure
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effects of neurally adjusted ventilatory assist on respiratory muscle fatigue in acute respiratoy failure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diaphragm function
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 neurally adjusted ventilatory assist
Interventions/Control_2 pressure support ventilation
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 patients with acute respiratory failure
Key exclusion criteria 1) Patients' refusal to participate in clinical research

2) General contraindications for gastric tube placement
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name NAOYUKI FUJIMURA
Organization St. Mary's Hospital
Division name Department of Anesthesiology
Zip code
Address 422 Tsubukuhonmachi Kurume, Fukuoka
TEL 0942-35-3322
Email n-fujimura@st-mary-med.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name NAOYUKI FUJIMURA
Organization St. Mary's Hospital
Division name Department of Anesthesiology
Zip code
Address 422 Tsubukuhonmachi Kurume, Fukuoka
TEL 0942-35-3322
Homepage URL
Email n-fujimura@st-mary-med.or.jp

Sponsor
Institute St. Mary's Hospital
Institute
Department

Funding Source
Organization St. Mary's Hospital
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 YES
Study ID_1 13-1003
Org. issuing International ID_1 St. Mary's Hospital
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 06 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 16 Day
Last modified on
2018 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037645

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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