Development of a Tracheal Sound Sensor

NCT05506267 | Completed

• 3 other identifiers: 20C.100152941R41DA047779-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Respiratory Insufficiency; Opioid Overdose; Hypoventilation

Outcome Measures

Primary Outcomes (5)

• Develop an algorithm that utilizes the Trachea Sound Sensor sound data to measure respiratory rate with sufficient accuracy for clinical care.

  The wearable Trachea Sound Sensor (TSS) will measure and analyze the sounds of air flow in the trachea during inhalation and exhalation to calculate respiratory rate (RR). Calibrated pneumotachs attached to a tight fitting face mask and a capnometer will be used to simultaneously measure the patient's RR. TSS measurements and reference respiratory measurements will be analyzed and correlated using a transfer function algorithm to calculate respiratory rate with sufficient accuracy for clinical care (+/- 1 breath per minute accuracy)

  24 hours

• Develop an algorithm that utilizes the Trachea Sound Sensor sound data to measure tidal volume (TV) with sufficient accuracy for clinical care.

  The wearable Trachea Sound Sensor (TSS) will measure and analyze the sounds of air flow in the trachea during inhalation and exhalation to calculate tidal volume (TV). Calibrated pneumotachs attached to a tight fitting face mask will be used to simultaneously measure the patient's TV. TSS measurements and reference respiratory measurements will be analyzed and correlated using a transfer function algorithm to calculate an approximate tidal volume with sufficient accuracy for clinical care (+/- 100 milliliters per breath accuracy)

  24 hours

• Develop an algorithm that utilizes the Trachea Sound Sensor sound data to measure tidal volume (TV) with sufficient accuracy for clinical care.

  The wearable Trachea Sound Sensor (TSS) will measure and analyze the sounds of air flow in the trachea during inhalation and exhalation to calculate tidal volume (TV). Calibrated pneumotachs attached to a tight fitting face mask will be used to simultaneously measure the patient's TV. TSS measurements and reference respiratory measurements will be analyzed and correlated using a transfer function algorithm to calculate tidal volume with sufficient accuracy for clinical care. TSS measurements of TV will be categorized into one of five bands (normal TV, decreased TV, very decreased TV, increased TV, very increased TV) with 95% accuracy.

  24 hours

• Develop an algorithm that utilizes the Trachea Sound Sensor sound data to measure the duration of apnea with sufficient accuracy for clinical care.

  The wearable Trachea Sound Sensor (TSS) will measure and analyze the sounds of air flow in the trachea during inhalation and exhalation to calculate duration of apnea (seconds). Calibrated pneumotachs attached to a tight fitting face mask and a capnometer will be used to simultaneously measure the duration of apnea. TSS measurements and reference respiratory measurements will be analyzed and correlated using a transfer function algorithm to calculate the duration of apnea (10 to 15 seconds, 16 to 30 seconds, \> 30 seconds) with 95% accuracy.

  24 hours

• Development of a Diagnostic Algorithm with a Risk-Index Score that Detects and Predicts Hypoventilation due to Opioids and Anesthetic Medications

  A wearable Trachea Sound Sensor (TSS) will measure and analyze the sounds of air flow in the trachea during inhalation and exhalation to calculate RR, TV, and duration of apnea. A commercial pulse oximeter will simultaneously measure heart rate and hemoglobin oxygen saturation. A commercial capnometer will simultaneously measure respiratory rate, duration of apnea, and end-tidal carbon dioxide concentration. The TSS measurements and reference respiratory measurements will be recorded and analyzed to develop a diagnostic algorithm with a risk index score (RIS) that detects/predicts the progression from normal ventilation to hypoventilation due to opioids and other medications that cause respiratory depression. The TSS and vital sign trend data will be analyzed to produce a Risk-Index Score updated every 30 seconds with alerts that warn the patient and caregivers about progressive Opioid Induced Respiratory Depression (OIRD) with \> 90% sensitivity and specificity.

  24 hours

Interventions

Trachea Sound Sensor (TSS) DEVICE

Use the TSS and commercial vital sign monitors to develop a diagnostic algorithm that detects and predicts hypoventilation due to opioids and anesthetic medication

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for inpatient surgery at Thomas Jefferson University Hospital that would routinely receive opioids for their clinical care.

You may qualify if:

• Patients scheduled for inpatient surgery at Thomas Jefferson University Hospital that would routinely receive opioids for their clinical care.
• Age 18 to 80 years.
• Body Mass Index \< 35.
• Stable lung function, oxygenation, and ventilation prior to the surgical procedure.
• Stable cardiac, vascular, renal, hepatic, neurologic, gastrointestinal, or muscular function prior to the surgical procedure

You may not qualify if:

• Patients scheduled for inpatient surgery at TJUH that would not routinely receive opioids for their clinical care.
• Age \< 18 and \> 80 years.
• Body Mass Index \> 35.
• History of difficult airway management or difficult endotracheal intubation
• History of severe seep apnea, requiring oxygen therapy, or CPAP management at home.
• Unstable pulmonary, cardiac, vascular, renal, hepatic, immune, neurologic, gastrointestinal, or muscular function prior to the surgical procedure.
• Excessive facial hair that may prevent a tight seal around the respiratory facemask.
• Pregnancy
• Patients that decline to participate

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• RTM Vital Signs, LLC: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (7)

• Yadollahi A, Moussavi ZM. Acoustical respiratory flow. A review of reliable methods for measuring air flow. IEEE Eng Med Biol Mag. 2007 Jan-Feb;26(1):56-61. doi: 10.1109/memb.2007.289122. No abstract available.

  PMID: 17278773 BACKGROUND

• Volkow ND, Collins FS. The Role of Science in the Opioid Crisis. N Engl J Med. 2017 Nov 2;377(18):1798. doi: 10.1056/NEJMc1711494. No abstract available.

  PMID: 29117474 BACKGROUND

• Yu L, Ting CK, Hill BE, Orr JA, Brewer LM, Johnson KB, Egan TD, Westenskow DR. Using the entropy of tracheal sounds to detect apnea during sedation in healthy nonobese volunteers. Anesthesiology. 2013 Jun;118(6):1341-9. doi: 10.1097/ALN.0b013e318289bb30.

  PMID: 23407106 BACKGROUND

• Ramsay MA, Usman M, Lagow E, Mendoza M, Untalan E, De Vol E. The accuracy, precision and reliability of measuring ventilatory rate and detecting ventilatory pause by rainbow acoustic monitoring and capnometry. Anesth Analg. 2013 Jul;117(1):69-75. doi: 10.1213/ANE.0b013e318290c798. Epub 2013 Apr 30.

  PMID: 23632055 BACKGROUND

• Mildh LH, Scheinin H, Kirvela OA. The concentration-effect relationship of the respiratory depressant effects of alfentanil and fentanyl. Anesth Analg. 2001 Oct;93(4):939-46. doi: 10.1097/00000539-200110000-00028.

  PMID: 11574361 BACKGROUND

• Shafer SL, Varvel JR, Aziz N, Scott JC. Pharmacokinetics of fentanyl administered by computer-controlled infusion pump. Anesthesiology. 1990 Dec;73(6):1091-102. doi: 10.1097/00000542-199012000-00005.

  PMID: 2248388 BACKGROUND

• Chen G, de la Cruz I, Rodriguez-Villegas E. Automatic lung tidal volumes estimation from tracheal sounds. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1497-500. doi: 10.1109/EMBC.2014.6943885.

  PMID: 25570253 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Opiate Overdose; Hypoventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen McNulty, DO

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 18, 2022
• Study Start: June 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)