Respiratory InsufficiencyNCT05506267
Development of a Tracheal Sound Sensor
An observational study of Respiratory Insufficiency and Opioid Overdose, run by Thomas Jefferson University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Insufficiency, Opioid Overdose, Hypoventilation
- What is being tested?
- Trachea Sound Sensor (TSS)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for inpatient surgery at Thomas Jefferson University Hospital that would routinely receive opioids for their clinical care.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Excessive facial hair that may prevent a tight seal around the respiratory facemask.
- Pregnancy
- Patients that decline to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Development of a Tracheal Sound Sensor for Early Detection of Hypoventilation
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).
Read more
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).
Read the detailed description
RTM's Trachea Sound Sensor (TSS) and data acquisition system will be used to measure and record the sounds of air movement within the trachea during inhalation/exhalation prior to surgery (baseline), and during management with opioid medications in the operating room (OR), post-anesthesia care unit (PACU), intensive care unit (ICU), and/or general nursing floor.
The TSS will be adhered to the skin of the neck (within the sternal notch) to measure and record the sounds of air flowing through the proximal trachea during inhalation and exhalation. A commercial miniature accelerometer sensor may also be adhered to the skin of the neck and used to measure and record the patient's body position and activity level.
In addition, research staff will intermittently measure and record each patient's respiratory rate (RR) and tidal volume (TV) prior to surgery (baseline), during anesthesia (OR), during anesthesia recovery (PACU), and during post-operative care (ICU or nursing floor) using a commercial research facemask and respiratory flow sensors (pneumotachs) hardwired to a data acquisition system and personnel computer (PC). One commercial pneumotach will accurately measure the patient's tidal volume during inhalation, and another commercial pneumotach will accurately measure the patient's tidal volume during exhalation.
The concentration of oxygen in the inspired air delivered into the facemask will be tightly controlled, according to a physician's order and standard-of-care methods. The facemask and commercial ventilation measurement system was designed and tested in collaboration with Nick Rudolph from the company Hans Rudolph, Inc.
Capnography will also be used to continuously measure and record the concentration of carbon dioxide within the facemask's air during inhalation and exhalation, using end-tidal measurements to estimate the concentration carbon dioxide in the alveoli and arterial blood. Hemoglobin oxygen saturation will be continuously measured and recorded using a commercial pulse oximeter and finger probe.
In some of the study subjects, blood will be intermittently sampled from a radial artery catheter (previously inserted for clinical care) or a peripheral venous catheter and used to measure the levels of pH, oxygen, carbon dioxide, lactate and other analytes using a point-of- care meter. Blood may be sampled more frequently before and after an opioid bolus or a change in opioid dose. Blood will not be sampled from some of the study subjects because a radial artery/venous catheter were not available or functional for blood sample acquisition.
Trend data will be used to develop a diagnostic algorithm with a risk-index score that detects/predicts progression from mild hypoventilation, to moderate hypoventilation, to severe hypoventilation due to opioids
- Conditions
- Respiratory Insufficiency, Opioid Overdose, Hypoventilation
- Being tested
- Trachea Sound Sensor (TSS)
- Medical subject headings
- Respiratory Insufficiency, Opiate Overdose, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Jun 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), RTM Vital Signs, LLC
- Responsible party
- Sponsor
- Investigators
- Stephen McNulty, DO, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506267
- Sponsor's protocol ID
- 20C.100
- Other IDs
- 15294, 1R41DA047779-01
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17278773Volkow 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.
PubMed 29117474Yu 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.
PubMed 23407106Ramsay 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.
PubMed 23632055Mildh 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.
PubMed 11574361Shafer 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.
PubMed 2248388Chen 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.
PubMed 25570253
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Tracheal Sound Sensor for Early Detection of Hypoventilation
- ClinicalTrials.gov ID
- NCT05506267
- Acronym / sponsor ID
- 20C.100
- Conditions
- Respiratory Insufficiency, Opioid Overdose, Hypoventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), RTM Vital Signs, LLC
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
RTM's Trachea Sound Sensor (TSS) and data acquisition system will be used to measure and record the sounds of air movement within the trachea during inhalation/exhalation prior to surgery (baseline), and during management with opioid medications in the operating room (OR), post-anesthesia care unit (PACU), intensive care unit (ICU), and/or general nursing floor.
The TSS will be adhered to the skin of the neck (within the sternal notch) to measure and record the sounds of air flowing through the proximal trachea during inhalation and exhalation. A commercial miniature accelerometer sensor may also be adhered to the skin of the neck and used to measure and record the patient's body position and activity level.
In addition, research staff will intermittently measure and record each patient's respiratory rate (RR) and tidal volume (TV) prior to surgery (baseline), during anesthesia (OR), during anesthesia recovery (PACU), and during post-operative care (ICU or nursing floor) using a commercial research facemask and respiratory flow sensors (pneumotachs) hardwired to a data acquisition system and personnel computer (PC). One commercial pneumotach will accurately measure the patient's tidal volume during inhalation, and another commercial pneumotach will accurately measure the patient's tidal volume during exhalation.
The concentration of oxygen in the inspired air delivered into the facemask will be tightly controlled, according to a physician's order and standard-of-care methods. The facemask and commercial ventilation measurement system was designed and tested in collaboration with Nick Rudolph from the company Hans Rudolph, Inc.
Capnography will also be used to continuously measure and record the concentration of carbon dioxide within the facemask's air during inhalation and exhalation, using end-tidal measurements to estimate the concentration carbon dioxide in the alveoli and arterial blood. Hemoglobin oxygen saturation will be continuously measured and recorded using a commercial pulse oximeter and finger probe.
In some of the study subjects, blood will be intermittently sampled from a radial artery catheter (previously inserted for clinical care) or a peripheral venous catheter and used to measure the levels of pH, oxygen, carbon dioxide, lactate and other analytes using a point-of- care meter. Blood may be sampled more frequently before and after an opioid bolus or a change in opioid dose. Blood will not be sampled from some of the study subjects because a radial artery/venous catheter were not available or functional for blood sample acquisition.
Trend data will be used to develop a diagnostic algorithm with a risk-index score that detects/predicts progression from mild hypoventilation, to moderate hypoventilation, to severe hypoventilation due to opioids
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for inpatient surgery at Thomas Jefferson University Hospital that would routinely receive opioids for their clinical care.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trachea Sound Sensor (TSS)Use the TSS and commercial vital sign monitors to develop a diagnostic algorithm that detects and predicts hypoventilation due to opioids and anesthetic medication | Device | – |
Primary outcome
Develop an algorithm that utilizes the Trachea Sound Sensor sound data to measure respiratory rate with sufficient accuracy for clinical care.
Time frame: 24 hours
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)
Develop an algorithm that utilizes the Trachea Sound Sensor sound data to measure tidal volume (TV) with sufficient accuracy for clinical care.
Time frame: 24 hours
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)
Develop an algorithm that utilizes the Trachea Sound Sensor sound data to measure tidal volume (TV) with sufficient accuracy for clinical care.
Time frame: 24 hours
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.
Develop an algorithm that utilizes the Trachea Sound Sensor sound data to measure the duration of apnea with sufficient accuracy for clinical care.
Time frame: 24 hours
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.
Development of a Diagnostic Algorithm with a Risk-Index Score that Detects and Predicts Hypoventilation due to Opioids and Anesthetic Medications
Time frame: 24 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 17278773Yadollahi 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.
- Background: PubMed 29117474Volkow 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.
- Background: PubMed 23407106Yu 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.
- Background: PubMed 23632055Ramsay 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.
- Background: PubMed 11574361Mildh 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.
- Background: PubMed 2248388Shafer 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.
- Background: PubMed 25570253Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen McNulty, DO principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency and Opioid Overdose, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop an algorithm that utilizes the Trachea Sound Sensor sound data to measure respiratory rate with sufficient accuracy for clinical care. (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05506267, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.