NCT06218017

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 2, 2024

Last Update Submit

January 11, 2024

Conditions

Endoscopy, GastrointestinalSedation, Conscious

Keywords

Tracheal soundElectronic auscultationHigh flow nasal oxygen

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

HFNO first

EXPERIMENTAL

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

HFNO later

ACTIVE COMPARATOR

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

Interventions

High flow nasal oxygen fistDEVICE

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).

HFNO first
High flow nasal oxygen laterDEVICE

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)

HFNO later

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing elective gastroinestinal endoscoy requiring deep sedation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Tawain University Hospital Hsinchu branch

Hsinchu, 300, Taiwan

RECRUITING

National Tawain University Hospital Hsinchu branch

Hsinchu, 300, Taiwan

RECRUITING

Central Study Contacts

Chun-Yu Wu, MD

CONTACT

800-555-5555b001089018@tmu.edu.tw

Tsung-Da Wu

CONTACT

800-555-5555tsungta.wu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 23, 2024

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
ANALYTIC CODE
Time Frame
20-30 min
Access Criteria
By contacting the principle investigator on the basis of rational research purpose.

Locations

TW(2)