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NCT05506267
Development of a Tracheal Sound Sensor
trial testing Trachea Sound Sensor (TSS) in Respiratory Insufficiency in 20 participants. Completed in 30 April 2022.
30 April 2022
Quick facts
| Lead sponsor | Thomas Jefferson University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 1 June 2020 |
| Primary completion | 30 April 2022 |
| Estimated completion | 30 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Trachea Sound Sensor (TSS)
Conditions studied
- Respiratory Insufficiency — all drugs for Respiratory Insufficiency →
- Opioid Overdose — all drugs for Opioid Overdose →
- Hypoventilation — all drugs for Hypoventilation →
Sponsor
Thomas Jefferson University
Who can join
Adults 18 to 80, any sex, with Respiratory Insufficiency or Opioid Overdose. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 episodes, and degree of snoring. A commercial accelerometer may be coupled to the skin surface of the neck (with tape) to measure body position and activity level. The TSS and vital sign trend data will be analyzed to produce a Risk-Index Score every 30 seconds with alerts and alarms that warn the patient and caregivers about progressive Opioid Induced Respiratory Depression (OIRD).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05506267
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Related trials
Other recruiting trials for Respiratory Insufficiency
Currently open trials in the same condition.
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- NCT05906030 — Diaphragm Dysfunction and Ultrasound Perioperatively · recruiting
- NCT06442267 — Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support · Phase 4 · recruiting
- NCT06494215 — Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Mechanically Ventilated Pa · NA · recruiting
Other Thomas Jefferson University trials
Trials by the same sponsor.
- NCT07526480 — Improving Dementia Care in Primary Practice · NA · not yet recruiting
- NCT07414550 — Radiotherapy for Refractory Hidradenitis Suppurativa · NA · not yet recruiting
- NCT07402018 — Intra-aortic Balloon Counterpulsation (IABC) Compliance · recruiting
- NCT07217197 — Respiratory Monitoring System That Detects & Predicts OIRD · NA · enrolling by invitation
- NCT07145099 — The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05506267 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Thomas Jefferson University
- Last refreshed: 18 August 2022
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