Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06218017
Other study ID # 202310040DINC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04743726 - Research on the Physiological Characteristics of the Gastrointestinal Tract in Chinese Volunteers
Terminated NCT00341523 - Early Detection of Esophageal Cancer
Not yet recruiting NCT06419543 - Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy
Not yet recruiting NCT05851885 - Evaluation of the Clinical Effectiveness of Upper Gastrointestinal Endoscopy Reporting System N/A
Completed NCT03724565 - Air Quality Check in Gastrointestinal Endoscopy Unit
Completed NCT02472730 - Cap Assisted Colonoscopy Enhances Quality Based Competency in Colonoscopy Among Trainees N/A
Recruiting NCT05851716 - Upper Gastrointestinal Endoscopy Reporting System in Improving Report Quality
Recruiting NCT05009212 - Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture N/A