Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062861) titled 'Impact of High-Flow Nasal Cannula flow rate on Swallowing: Comparing Symmetrical and Asymmetrical Cannulas' on Sept. 9.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Kurume University

Condition: Condition - healthy adult volunteers who were healthcare professionals Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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

Eligibility: Age-lower limit - 20 years-old 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 Size - 10

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071963

Disclaimer: Curated by HT Syndication.