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NCT05506267 · ClinicalTrials.gov registry record
Development of a Tracheal Sound Sensor
A clinical trial of Respiratory Insufficiency and Opioid Overdose, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT05506267 is a study of Respiratory Insufficiency and Opioid Overdose that has completed, run by Thomas Jefferson University. The registered enrollment target is 20 participants, below the 749-participant average among 10 other Respiratory Insufficiency trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05506267, a study of Respiratory Insufficiency and Opioid Overdose, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
An observational study will be conducted in 20 hospitalized surgical patients routinely managed with opioids for anesthesia and post-operative pain control. Trachea Sound Sensor measurements and reference respiratory measurements will be recorded and analyzed to develop diagnostic algorithms that produce a risk-index score that detects/predicts progression from mild hypoventilation, to moderate hypoventilation, to severe hypoventilation due to opioids and other medications that cause respiratory depression. Our current Trachea Sound Sensor (TSS) has a wired Sony commercial microphone integrated into a commercial pediatric stethoscope, coupled to the skin surface over the trachea at the sternal notch. The Trachea Sound Sensor will measure and record the sounds of air moving within the proximal trachea during inhalation and exhalation. The microphone signal will be converted into an accurate measurement of the patient's respiratory rate and tidal volume (during inhalation \& exhalation) over time, to determine the minute ventilation trend, breathing patterns, apnea episodes, and degree of snoring (due to partial upper airway obstruction). A commercial respiratory facemask and two pneumotachs (gas flow sensors) will also be used to accurately and continuously measure the patient's respiratory rate and tidal volume (during inhalation \& exhalation) to determine the minute ventilation trend, breathing patterns, and apnea episodes. TSS data and reference respiratory data will be collected prior to surgery with the patient breathing normally (baseline), in the Operating Room (OR) during the induction and maintenance of anesthesia, in the Post Anesthesia Care Unit (PACU), and on the general nursing floors of Thomas Jefferson University Hospital (TJUH). The sounds of air flowing through the proximal trachea will be correlated with the reference breathing measurements using signal processing methods to optimize the measurement accuracy of RR, TV, breathing pattern, apnea
Conditions Studied
Interventions
- DEVICE Trachea Sound Sensor (TSS)
Study Locations (1)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2022-04-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05506267
The ClinicalTrials.gov registry entry for NCT05506267 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 749-participant average among 10 other Respiratory Insufficiency trials with a reported enrollment target (97% lower). The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Respiratory Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which Trachea Sound Sensor (TSS) is the first listed.
NCT05506267 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05506267 about?
NCT05506267 is a clinical study titled "Development of a Tracheal Sound Sensor". An observational study will be conducted in 20 hospitalized surgical patients routinely managed with opioids for anesthesia and post-operative pain control. Trachea Sound Sensor measurements and reference respiratory measurements will be recorded and analyzed to develop diagnostic algorithms that pr...
What is the current status of trial NCT05506267?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2020-06-01. Estimated completion is 2022-04-30.
What conditions does trial NCT05506267 study?
This clinical trial studies the following conditions: Respiratory Insufficiency, Opioid Overdose, Hypoventilation.
What interventions are being tested in trial NCT05506267?
The interventions under investigation include: Trachea Sound Sensor (TSS) (DEVICE).
Who is sponsoring clinical trial NCT05506267?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05506267 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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