UMIN-ICDS Clinical Trial

Public title

Impact of High-Flow Nasal Cannula flow rate on Swallowing: Comparing Symmetrical and Asymmetrical Cannulas

Acronym

Impact of High-Flow Nasal Cannula flow rate on Swallowing: Comparing Symmetrical and Asymmetrical Cannulas

Scientific Title

Impact of High-Flow Nasal Cannula flow rate on Swallowing: Comparing Symmetrical and Asymmetrical Cannulas

Scientific Title:Acronym

Impact of High-Flow Nasal Cannula flow rate on Swallowing: Comparing Symmetrical and Asymmetrical Cannulas

Region

Japan

Condition

healthy adult volunteers who were healthcare professionals

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to compare and evaluate the effects of high flow nasal cannula application using an asymmetric cannula versus a conventional symmetric cannula on swallowing/respiration patterns and swallowing function in healthy adults.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Primary Outcome Measure:
Swallowing/respiration pattern (e.g., respiratory phase preceding and following swallows) during the Repetitive Saliva Swallowing Test (RSST).
Timepoint(s): At baseline (without cannula) and at flow rates of 30 L/min, 40 L/min, 50 L/min, and 60 L/min. A 2 minute washout period is allowed when changing flow rates. Measurements are performed at least 10 seconds after confirming that the equipment and the participant's respiratory status have stabilized under each condition.

Key secondary outcomes

Outcome Measures:
Number of swallows within 30 seconds during the Repetitive Saliva Swallowing Test (RSST), Duration of laryngeal movement during the RSST (seconds),
Presence or absence of choking/coughing during the RSST,Subjective rating of swallowing difficulty during the RSST evaluated by Numeric Rating Scale (NRS), Thoracic movement (changes in amplitude and cycle of thoracic respiratory motion) during the RSST
Timepoint(s): At baseline (without cannula) and at flow rates of 30 L/min, 40 L/min, 50 L/min, and 60 L/min. A 2 minute washout period is allowed when changing flow rates. Measurements are performed at least 10 seconds after confirming that the equipment and the participant's respiratory status have stabilized under each condition.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Following screening, participants sequentially wear a symmetrical cannula and an asymmetrical cannula to evaluate swallowing function under high-flow nasal cannula (HFNC) therapy.

1. Screening and Preliminary Examination:

Rhinomanometry testing is performed using a rhinomanometer (MPR-3100); individuals with a resistance value of 0.25 or higher are excluded. Endoscopic evaluation of swallowing function is conducted by an otolaryngologist, and individuals with functional abnormalities are excluded.

The Repetitive Saliva Swallowing Test (RSST) is performed in the baseline state without wearing any device.

2. First Phase Intervention:

Attach the symmetrical cannula.

Perform the RSST at each flow rate while randomly varying the flow rate (0 L/min, 30 L/min, 40 L/min, 50 L/min, and 60 L/min). Swallowing motion is evaluated by measuring laryngeal movement time and number of swallows using a wearable sensor system (B4S) and a video flexible nasopharyngoscope [ENF-VH, OLYMPUS]. Respiratory movement is measured using a specialized elastic band integrated with a C-STRETCH sensor.

Before changing each flow rate, set the flow rate to 0 L/min for a 1-minute washout period.

3. Second Phase Intervention:

Attach the asymmetrical cannula.

Similarly, perform the RSST while randomly varying the flow rate (30 L/min, 40 L/min, 50 L/min, and 60 L/min), with a 1-minute washout period (0 L/min) prior to each flow rate change.

* Throughout all tests, the B4S respiratory unit and respiratory belt are worn to simultaneously measure and evaluate laryngeal movement waveforms and respiratory waveforms.

Duration of Intervention: 1 day (single session of approximately 30 minutes)

Dose / Volume of Intervention: Flow rates: 0 L/min, 30 L/min, 40 L/min, 50 L/min, and 60 L/min

Frequency of Intervention: Single session only on 1 day; RSST performed once at each flow rate

Interventions/Control_2

Following screening, participants sequentially wear an asymmetrical cannula and a symmetrical cannula to evaluate swallowing function under high-flow nasal cannula (HFNC) therapy.

1. Screening and Preliminary Examination:

Rhinomanometry testing is performed using a rhinomanometer (MPR3100); individuals with a resistance value of 0.25 or higher are excluded. Endoscopic evaluation of swallowing function is conducted by an otolaryngologist, and individuals with functional abnormalities are excluded.

The Repetitive Saliva Swallowing Test (RSST) is performed in the baseline state without wearing any device.

2. First Phase Intervention:

Attach the asymmetrical cannula.

Perform the RSST at each flow rate while randomly varying the flow rate (0 L/min, 30 L/min, 40 L/min, 50 L/min, and 60 L/min). Swallowing motion is evaluated by measuring laryngeal movement time and number of swallows using a wearable sensor system (B4S) and a video flexible nasopharyngoscope [ENF-VH, OLYMPUS]. Respiratory movement is measured using a specialized elastic band integrated with a C-STRETCH sensor.

Before changing each flow rate, set the flow rate to 0 L/min for a 1-minute washout period.

3. Second Phase Intervention:

Attach the symmetrical cannula.

Similarly, perform the RSST while randomly varying the flow rate (30 L/min, 40 L/min, 50 L/min, and 60 L/min), with a 1-minute washout period (0 L/min) prior to each flow rate change.

* Throughout all tests, the B4S respiratory unit and respiratory belt are worn to simultaneously measure and evaluate laryngeal movement waveforms and respiratory waveforms.

Duration of Intervention: 1 day (single session of approximately 30 minutes)

Dose / Volume of Intervention: Flow rates: 0 L/min, 30 L/min, 40 L/min, 50 L/min, and 60 L/min

Frequency of Intervention: Single session only on 1 day; RSST performed once at each flow rate

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy adult subjects (including healthcare professionals)
Individuals who have provided written informed consent to participate in the study
Individuals with nasal resistance less than 0.25 (or < 0.5) as measured by rhinomanometry (MPR-3100)
Individuals with no structural or functional abnormalities confirmed by endoscopic swallowing evaluation performed by an otorhinolaryngologist

Key exclusion criteria

Individuals with a nasal resistance of 0.25 or higher (or > 0.5 ) as measured by rhinomanometry (MPR3100).
Individuals with structural or functional abnormalities detected during endoscopic examination by an otorhinolaryngologist.
Individuals judged by the collaborating physician to have difficulty with nasal endoscopic insertion.
Individuals who belong to the same department and hold the same job title/position as the principal investigator or sub-investigator.

Target sample size

10

Name of lead principal investigator

1st name	KAN
Middle name
Last name	SUGISHIMA

Organization

Kurume University Hospital

Division name

Nursing Department

Zip code

8300011

Address

67 Asahi-machi, Kurume-shi, Fukuoka, Japan

TEL

0942353311

Email

sugishima_kan@kurume-u.ac.jp

Name of contact person

1st name	KAN
Middle name
Last name	SUGISHIMA

Organization

Kurume University Hospital

Division name

Nursing Department

Zip code

8300011

Address

67 Asahi-machi, Kurume-shi, Fukuoka, Japan

TEL

0942353311

Homepage URL

Email

sugishima_kan@kurume-u.ac.jp

Institute

Kurume University

Institute

Department

Personal name

Organization

KIMURA FOUNDATION FOR NURSING EDUCATION

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

The Ethical Committee of Kurume University (medical ethics)

Address

67 Asahi-machi, Kurume-shi, Fukuoka, Japan

Tel

0942353311

Email

i_rinri@kurume-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

12

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

Recruitment status

Completed

Date of protocol fixation

2025

Year

04

Month

30

Day

Date of IRB

2025

Year

06

Month

26

Day

Anticipated trial start date

2026

Year

01

Month

10

Day

Last follow-up date

2026

Year

04

Month

16

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

09

Month

09

Day

Last modified on

2026

Year

09

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071963