Development of an Algorithm to Denoise HFNO-generated Tracheal Sound

Development of Algorithm to Precise Monitoring Respiratory Sound During Deep Sedation Using the High Flow Nasal Oxygen System

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06218017

Enrollment

Registered

2024-01-23

Start date

2024-01-31

Completion date

2025-01-31

Last updated

2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopy, Gastrointestinal, Sedation, Conscious

Keywords

Tracheal sound, Electronic auscultation, High flow nasal oxygen

Brief summary

This study aims to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.

Detailed description

During deep sedation without intubation, anesthesia respiratory care and monitoring are of utmost importance. Anesthesia can lead to adverse respiratory effects, increasing the risk of airway obstruction and respiratory depression. High-flow nasal oxygen (HFNO) systems are often used to mitigate these risks. Monitoring tracheal breathing sounds directly using amplification provides better detection accuracy. However, traditional auscultation instruments have limitations, including noise interference and lack of visual functionality. The Airmod Smart Respiratory Monitoring System, with FDA approval in the United States and Taiwan, addresses these issues. It offers respiratory sound recording, noise filtering, event logging, and respiratory rate analysis. Currently, no digital stethoscope on the market can filter out HFNO noise. Therefore, the current study is to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.

Interventions

DEVICEHigh flow nasal oxygen fist

Patients in the two study group first underwent a 10-minute session of high-flow nasal oxygen (50 L/min) followed by the utilization of the standard low-flow nasal oxygen (4 L/min) or underwent a 10-minute session of standard low-flow nasal oxygen (4 L/min) followed by the utilization of the high-flow nasal oxygen (50 L/min).

DEVICEHigh flow nasal oxygen later

Patient in this group underwent a 10-minute session of standard low-flow nasal oxygen (4 L/min) followed by the utilization of the high-flow nasal oxygen (50 L/min)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients undergoing elective gastroinestinal endoscoy requiring deep sedation

Exclusion criteria

* Histories of sleep apnea, chronic obstructive pulmonary disease, or oropharyngeal tumor * Patient who has a hisotry of previous intraoral surgery, tracheal surgery or pulmonary resection surgery

Design outcomes

Primary

Measure	Time frame	Description
Tracheal sound with and without high-flow nasal oxygen will be measured to develop an algorithm to mitigate the high flow nasal oxygen-generated tracheal noise	20-30 minutes	We aim to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen based on recording the tracheal sound of patients undergoing gastrointestinal endoscopy in deep sedation with and without high flow nasal oxygen

Countries

Taiwan

Contacts

Primary ContactChun-Yu Wu, MD

b001089018@tmu.edu.tw800-555-5555

Backup ContactTsung-Da Wu

tsungta.wu@gmail.com800-555-5555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026