Development of an Algorithm to Denoise HFNO-generated Tracheal Sound

January 11, 2024 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Hsinchu, Taiwan, 300
        • Recruiting
        • National Tawain University Hospital Hsinchu branch
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chun-Yu Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HFNO first
This study follows a crossover design employing a randomized controlled methodology. Patients undergoing gastrointestinal endoscopy and receiving deep sedation were monitored using electronic tracheal sound auscultation. Within this group, patients 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). Electronic tracheal sound recordings were obtained during both the high-flow and low-flow nasal oxygen administrations. The aim is to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen.
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).
Active Comparator: HFNO later
This study follows a crossover design employing a randomized controlled methodology. Patients undergoing gastrointestinal endoscopy and receiving deep sedation were monitored using electronic tracheal sound auscultation. Within this group, patients first 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). Electronic tracheal sound recordings were obtained during both the high-flow and low-flow nasal oxygen administrations. The aim is to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen
Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
20-30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Estimated)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202310040DINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD will be shared by contacting the principle investigator for rational research purpose.

IPD Sharing Time Frame

20-30 min

IPD Sharing Access Criteria

By contacting the principle investigator on the basis of rational research purpose.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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