UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055780 |
|---|---|
| Receipt number | R000063749 |
| Scientific Title | A study on the effects and comfort of a non-symmetrical high-flow nasal oxygen cannula |
| Date of disclosure of the study information | 2024/10/21 |
| Last modified on | 2024/10/08 14:45:49 |
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Basic information
Public title
A study on the effects and comfort of a non-symmetrical high-flow nasal oxygen cannula
Acronym
A study on the effects and comfort of a non-symmetrical high-flow nasal oxygen cannula
Scientific Title
A study on the effects and comfort of a non-symmetrical high-flow nasal oxygen cannula
Scientific Title:Acronym
A study on the effects and comfort of a non-symmetrical high-flow nasal oxygen cannula
Region
| Japan |
Condition
Condition
respiratory failure, heart failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will investigate whether a asymmetrical high-flow nasal cannula device provides improved carbon dioxide clearance and comfort compared to a conventional HFNC device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference in ventilation volume between devices will be used as the evaluation item.
The patient wears electrodes for electrical impedance tomography (EIT) so that the ventilation volume under spontaneous breathing can be estimated from the measured electrical resistance.
The patient wears each device and sets the flow rate provided by each device. After breathing naturally for 15 minutes, the ventilation volume is estimated using the electrical resistance recorded by EIT.
The estimated ventilation volume is compared between each device
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To compare the asymmetrical HFNC with the conventional HFNC, the devices will be fitted to the patient in turn(asymmetric -> conventional), and the effect of each will be verified by changing the flow rate provided. The order of fitting the asymmetrical device and the conventional device will be randomised.
Interventions/Control_2
To compare the asymmetrical HFNC with the conventional HFNC, the devices will be fitted to the patient in turn(conventional -> asymmetric), and the effect of each will be verified by changing the flow rate provided. The order of fitting the asymmetrical device and the conventional device will be randomised.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 and over who require treatment with HFNC at ICU.
Patients who are legally competent to give consent.
Key exclusion criteria
1) Patients with significant respiratory instability or respiratory acidosis, for whom the insertion and removal of the device is deemed to be dangerous
2) Pregnant patients
3) Patients with neuromuscular disorders
4) Patients who have difficulty following the breathing instructions given to them
5) Patients with extremely sensitive skin
6) Patients with nasogastric tubes in place
7) Patients deemed to be unsuitable for the procedure by the doctor
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Tobe |
Organization
Gunma university hospital
Division name
Intensive care unit
Zip code
371-8511
Address
3-39-15 Showa-machi, Mebashi-shi, Gunma prefecture
TEL
027-220-8698
tbc0211@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Sugimoto |
Organization
Gunma university hospital
Division name
Intensive care unit
Zip code
371-8511
Address
3-39-15 Showa-machi, Mebashi-shi, Gunma prefecture
TEL
027-220-8698
Homepage URL
k.sugimoto1003@gmail.com
Sponsor or person
Institute
Gunma university
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
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Mebashi-shi, Gunma prefecture
Tel
027-220-8740
irb-jimukk-ciru@ml.gunma-u.ac.jp
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
| 2024 | Year | 10 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063749
