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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014456
Receipt No. R000016812
Scientific Title Humidification performance of humidifying devices for tracheotomized patients with spontaneous breathing.
Date of disclosure of the study information 2014/09/01
Last modified on 2018/11/14

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Basic information
Public title Humidification performance of humidifying devices for tracheotomized patients with spontaneous breathing.
Acronym Humidifying devices for tracheotomized patients.
Scientific Title Humidification performance of humidifying devices for tracheotomized patients with spontaneous breathing.
Scientific Title:Acronym Humidifying devices for tracheotomized patients.
Region
Japan

Condition
Condition Tracheotomized patients
Classification by specialty
Intensive care medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate humidifying performance of heat and humidity exchanger for tracheotomized patients and high flow tracheotomy interface in clinical settings.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes temperature and humidity of expired gas
Key secondary outcomes

Base
Study type

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 heat and moist exchanger for tracheotomized patients
Interventions/Control_2 high flow tracheotomy interface
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Tracheotomized patients who are admitted in intensive care unit.
Key exclusion criteria trachal bleeding
shock
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Oto
Organization The University of Tokushima Graduate School
Division name Emergency and Critical Care Medicine
Zip code
Address 3-18-15 Kuramotocho Tokushima-city Tokushima Japan
TEL 088-633-9347
Email joto@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Oto
Organization The University of Tokushima Graduate School
Division name Emergency and Critical Care Medicine
Zip code
Address 3-18-15 Kuramotocho Tokushima-city Tokushima Japan
TEL 088-633-9347
Homepage URL
Email joto@tokushima-u.ac.jp

Sponsor
Institute The University of Tokushima Graduate School
Institute
Department

Funding Source
Organization The University of Tokushima Graduate School
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The temperature with the HME was 29.9 degree  and, during heated-and-humidified high-flow use was 35.3 degree (P < .001). With both the HME and the heated-and-humidified high-flow system, the relative humidity reached 100%; the absolute humidity with HME was 30.2 mg/L, and, with the heated-and-humidified high-flow system, was 40.3 mg/L (P < .001).
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
2014 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 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
2014 Year 07 Month 02 Day
Last modified on
2018 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016812

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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