Development of an Algorithm to Denoise HFNO-generated Tracheal Sound

Endoscopy, Gastrointestinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218017
• Other study ID #: 202310040DINC
• Status: Recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: National Taiwan University Hospital
• Contact: Chun-Yu Wu, MD
• Phone: 800-555-5555
• Email: b001089018[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endoscopy, Gastrointestinal
• Sedation, Conscious

Intervention

Device:
• High 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).
• High 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)

Locations

Country	Name	City	State
Taiwan	National Tawain University Hospital Hsinchu branch	Hsinchu
Taiwan	National Tawain University Hospital Hsinchu branch	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	20-30 minutes