Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose

NCT03845699 | Unknown

• 1 other identifier: 20183438,18C.7
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RTM Vital Signs, LLC is developing a miniature wearable tracheal sound sensor that communicates with a cell phone containing a machine-learning diagnostic algorithm designed to detect and predict the onset of mild, moderate, and severe hypoventilation (respiratory depression) due to an opioid overdose. The purpose of this clinical trial is to develop/validate diagnostic algorithms capable of detecting/predicting the onset of hypoventilation induced by a controlled intravenous infusion of fentanyl. The wearable sensor and algorithms will provide a series of alerts and alarms to the person, caregiver, and/or emergency personnel.

Conditions

Drug Overdose; Opioid-Related Disorders

Keywords

Opioid Overdose; Diagnostic Algorithm; Wearable Trachea Sound Sensor; Respiratory Depression; Hypoventilation

Outcome Measures

Primary Outcomes (3)

• Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Mild Hypoventilation due to an Opioid Overdose

  The investigators will evaluate the risk-index algorithm's ability to detect/predict at which point during the standardized fentanyl infusion protocol does mild hypoventilation actually occur. Calculate the percent sensitivity and specificity of detecting/predicting the onset of mild hypoventilation (PaCO2- 45 to 50 mm Hg) due to a fentanyl overdose.

  1 to 3 hours

• Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Moderate Hypoventilation due to an Opioid Overdose

  The investigators will evaluate the risk-index algorithm's ability to detect/predict at which point during the standardized fentanyl infusion protocol does moderate hypoventilation actually occur. Calculate the percent sensitivity and specificity of detecting/predicting the onset of mild hypoventilation (PaCO2- 51 to 60 mm Hg) due to a fentanyl overdose.

  1 to 3 hours

• Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Severe Hypoventilation due to an Opioid Overdose

  The investigators will evaluate the risk-index algorithm's ability to detect/predict at which point during the standardized fentanyl infusion protocol does severe hypoventilation actually occur. Calculate the percent sensitivity and specificity of detecting/predicting the onset of severe hypoventilation (PaCO2 \> 60 mm Hg) due to a fentanyl overdose.

  1 to 3 hours

Secondary Outcomes (1)

• Absolute Difference Between Trachea Sound Sensor's Measurements and Reference Sensor Measurements

  1 to 3 hours

Interventions

Diagnostic algorithms that detects/predicts hypoventilation DEVICE

Produce mild and moderate respiratory depression (hypoventilation) using a controlled intravenous infusion of fentanyl while measuring/recording respiratory rate, tidal volume, body activity, and body position.

Also known as: Infusion of fentanyl to induce hypoventilation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy males/females of all ethnic backgrounds, 18 to 40 years of age

You may qualify if:

• Healthy women/men between 18 and 40 years of age.
• Negative history of drug or alcohol abuse.
• Negative history of cigarette smoking in previous 6 months.
• Negative history of active cardiac, vascular, pulmonary, renal, hepatic, nervous, metabolic or immune disease.
• BMI \< 30

You may not qualify if:

• Age \< 18 years and \> 40 years.
• Pregnant or planning to become pregnant.
• Positive history drug or alcohol abuse.
• Positive drug screen for opioids, benzodiazepines, hypnotics.
• Positive Drug Abuse Screening Test result (score of 6 or greater).
• BMI \> 30
• History of sleep apnea.
• History of cigarette smoking in previous 6 months.
• History of difficult airway during anesthesia management.
• History of allergy or skin sensitivity to tape, silicone, fentanyl, chlorhexidine.

Sponsors & Collaborators

• RTM Vital Signs, LLC: lead
• Thomas Jefferson University: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (19)

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  PMID: 11574361 BACKGROUND

• Boyer EW. Management of opioid analgesic overdose. N Engl J Med. 2012 Jul 12;367(2):146-55. doi: 10.1056/NEJMra1202561. No abstract available.

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• Volkow ND, Collins FS. The Role of Science in Addressing the Opioid Crisis. N Engl J Med. 2017 Jul 27;377(4):391-394. doi: 10.1056/NEJMsr1706626. Epub 2017 May 31. No abstract available.

  PMID: 28564549 BACKGROUND

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  PMID: 17278773 BACKGROUND

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  PMID: 25570253 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

• Reyes BA, Reljin N, Chon KH. Tracheal sounds acquisition using smartphones. Sensors (Basel). 2014 Jul 30;14(8):13830-50. doi: 10.3390/s140813830.

  PMID: 25196108 BACKGROUND

• Stuth EA, Stucke AG, Zuperku EJ. Effects of anesthetics, sedatives, and opioids on ventilatory control. Compr Physiol. 2012 Oct;2(4):2281-367. doi: 10.1002/cphy.c100061.

  PMID: 23720250 BACKGROUND

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  PMID: 11385141 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.

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  PMID: 29184596 BACKGROUND

• Jin F, Goh DY, Louis IM. An Enhanced Respiratory Rate Montoring Method for Real Tracheal Sound Recordings. 17 European Signal Processing Conference. 2009:642- 645.

  BACKGROUND

• Harper VP, Pasterkamp H, Kiyokawa H, Wodicka GR. Modeling and measurement of flow effects on tracheal sounds. IEEE Trans Biomed Eng. 2003 Jan;50(1):1-10. doi: 10.1109/TBME.2002.807327.

  PMID: 12617519 BACKGROUND

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  BACKGROUND

• Kraman SS, Wodicka GR, Pressler GA, Pasterkamp H. Comparison of lung sound transducers using a bioacoustic transducer testing system. J Appl Physiol (1985). 2006 Aug;101(2):469-76. doi: 10.1152/japplphysiol.00273.2006. Epub 2006 Apr 20.

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• Lu BY. Unidirectional Microphone based Wireless Recorder for the Respiration Sound. J Bioengineer & Biomedical Sci. 2016;6(3).

  BACKGROUND

• Perus O, Marsot A, Ramain E, Dahman M, Paci A, Raucoules-Aime M, Simon N. Performance of alfentanil target-controlled infusion in normal and morbidly obese female patients. Br J Anaesth. 2012 Oct;109(4):551-60. doi: 10.1093/bja/aes211. Epub 2012 Jun 24.

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• 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

MeSH Terms

Conditions

Drug Overdose; Opioid-Related Disorders; Opiate Overdose; Respiratory Insufficiency; Hypoventilation

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephen McNulty, DO

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen McNulty, DO

CONTACT

215-955-6161; Stephen.McNulty@Jefferson.edu

Jeffrey I Joseph, DO

CONTACT

215-620-9999; Jeffrey.Joseph@Jefferson.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2019
• First Posted: February 19, 2019
• Study Start: May 15, 2019
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)