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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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