UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014456 |
|---|---|
| Receipt number | 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 11:19:04 |
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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
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
joto@tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016812
