UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031318 |
|---|---|
| Receipt number | R000035752 |
| Scientific Title | Humidification performance of a HME and a heated and humidified high flow (HHHF) for tracheostomized patients with spontaneous breathing |
| Date of disclosure of the study information | 2018/02/15 |
| Last modified on | 2018/10/19 10:48:32 |
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Basic information
Public title
Humidification performance of a HME and a heated and humidified high flow (HHHF) for tracheostomized patients with spontaneous breathing
Acronym
Humidification performance of a HME and a heated and humidified high flow (HHHF)
Scientific Title
Humidification performance of a HME and a heated and humidified high flow (HHHF) for tracheostomized patients with spontaneous breathing
Scientific Title:Acronym
Humidification performance of a HME and a heated and humidified high flow (HHHF)
Region
| Japan |
Condition
Condition
tracheostomized patients with spontaneous breathing
Classification by specialty
| Pneumology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare humidification performance of HNME and HHHF
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Absolute humidity
Key secondary outcomes
Tidal volume,end-tidal carbon dioxide (Et CO2), breathing frequency, SpO2, heart rate, and blood pressure.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
HHHF (heated and humidified high flow) was used for 1 hour
Optiflow, 40L/min
Interventions/Control_2
HME (Heat and moisture exchanger) was used for 1 hour
Trach vent+
Interventions/Control_3
HHHF (heated and humidified high flow) was used for 1 hour
Optiflow, 40L/min
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We included consecutive adult tracheostomized patients with spontaneous breathing who had been weaned from mechanical ventilation in the ICU.
Key exclusion criteria
We excluded patients who met the following criteria: 1) aged less than 18 years old, 2) patients who have too much secretions and difficulty in expelling secretions, 3) patients with severe respiratory or hemodynamic instability, 4) who need more than 1L/min of oxygen or fraction of inspired oxygen (FiO2) > 0.25.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuto Nakanishi |
Organization
Tokushima university hospital
Division name
Emergency and critical care medicine
Zip code
Address
2-50-1, Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-9347
nobuto_nakanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuto Nakanishi |
Organization
Tokushima university hospital
Division name
Emergency and critical care medicine
Zip code
Address
2-50-1, Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-9347
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
Tokushima university hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Secondary IDs
Secondary IDs
YES
Study ID_1
2033
Org. issuing International ID_1
Tokushima university hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/30254040
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30254040
Number of participants that the trial has enrolled
Results
Ten subjects were enrolled. The temperature with the HME was 29.9 and during heated-and-humidified high-flow use was 35.3 (P<.001). With both the HME and the heated-and-humidified high-flow system, the relative humidity reached 100%; absolute humidity with HME was 30.2 mg/L, and with the heated-and-humidified high-flow system, was 40.3 (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
| 2017 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 15 | Day |
Last modified on
| 2018 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035752
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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