UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057358 |
|---|---|
| Receipt number | R000065029 |
| Scientific Title | Comfort in high-flow nasal cannula oxygen therapy: a volunteer study |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/21 17:53:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of comfort under respiratory management with a high-flow nasal cannula: a volunteer study
Acronym
Comfort study of high-flow nasal cannulas: a volunteer study
Scientific Title
Comfort in high-flow nasal cannula oxygen therapy: a volunteer study
Scientific Title:Acronym
Comfort in high-flow nasal cannula oxygen therapy: a volunteer study
Region
| Japan |
Condition
Condition
Respiratory disorders, including respiratory failure
Classification by specialty
| Pneumology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
High-flow nasal cannula oxygen therapy (HFNCOT) is a noninvasive respiratory management technique for patients with respiratory disorders, including respiratory failure. An example of this is nasal high flow (NHF). Another example is non-invasive positive pressure ventilation (NPPV), which is unintubated continuous supportive ventilation (ventilatory management), although NPPV-treated patients have been shown to be more uncomfortable and anxious than NHF-treated patients (Suzuki Y, et al. J Intensive Care. J Intensive Care. 2014), but no quantitative assessment has been made to date.
This study aims to assess the level of comfort and stress caused by NHF use using multiple assessment methods.
Basic objectives2
Others
Basic objectives -Others
Non-intensive measurement of cerebral blood flow and cerebral oxygen saturation, balance of autonomic nervous system activity, and stress markers in saliva components, which may vary with different respiratory management methods, may contribute to establishing respiratory management methods with higher patient satisfaction. In other words, the use of NHFs may decrease the degree of stress caused by NHF use, as well as increase patient satisfaction and decrease refusal to wear NHFs.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective comfort level (VAS) for respiratory management methods
Key secondary outcomes
(i) Salivary stress markers (amylase concentration, salivary cortisol concentration, salivary sIgA concentration, salivary sIgG concentration)
(ii) Blood pressure (systolic, diastolic, average), pulse rate, SpO2, BIS value, sedation score
(iii) Heart rate variability by ECG RR interval
(iv) Tissue oxygenation index, tissue hemoglobin index, oxygenated hemoglobin change, deoxygenated hemoglobin change, total hemoglobin change by NIRS
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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
Respiratory management with Nasal High flow (from 30 to 60L/min)
Interventions/Control_2
Respiratory management with Nasal High flow (from 60 to 30L/min)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers 20 years of age or older who understand the purpose of this study and agree to participate in the research.
Key exclusion criteria
1. under 20 years of age
2. general status classification (ASA-PS classification) of the American Society of Anesthesiologists is 3 or higher
3. who have nasal obstruction and difficulty breathing through the nose on a daily basis (including those who experience epistaxis easily)
4. those with psychiatric disorders or those taking psychotropic drugs
5. patients who may not be able to measure EEG or BIS values properly (including those with brain lesions)
6. patients who have expressed (including verbally) their refusal to participate in this study
7. other patients who are judged by the principal investigator to be inappropriate to participate in the study.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Kanagawa Dental University
Division name
Department of Dental Anesthesiology
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa, Japan
TEL
046-822-8751
tsukimoto@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Atsuki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kanagawa Dental University
Division name
Department of Dental Anesthesiology
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa, Japan
TEL
046-822-8751
Homepage URL
yamaguchi.atsuki@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Kanagawa Dental University Ethics Review Committee
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa, Japan
Tel
046-822-8751
kenkyo@kdu.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
| 2025 | Year | 04 | Month | 01 | 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
| 2025 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | 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
| 2025 | Year | 03 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065029
