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

May 7, 2019 updated by: RTM Vital Signs, LLC
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

More than 64,000 Americans died from a drug overdose in 2016 and drug overdose is now the most common cause of death for people under 50 years old in the United States. The purpose of this study is to design a wearable tracheal sound sensor and develop an experimental computer program (diagnostic algorithm) that can accurately detect and predict the onset of mild, moderate, and severe hypoventilation (slow and shallow breathing) due to an opioid (fentanyl) overdose

Opioid pain medications routinely cause a person's breathing to become slower and shallower, leading to an increased amount of carbon dioxide and decreased amount of oxygen in the bloodstream. Microphone trachea sound sensors will be used to measure and record sounds produced by air movement in and out of a person's trachea (windpipe) during inhalation and exhalation. Blood will be frequently sampled from a catheter placed within a wrist artery to measure the concentration of carbon dioxide and oxygen. An intravenous infusion of fentanyl will be used to decrease the person's respiratory rate and depth of breathing over a 1 to 3 hour period. Other sensors will be used to accurately measure and record the person's respiratory rate, tidal volume, hemoglobin oxygen saturation, electrocardiogram, blood pressure, temperature, body activity level, and body position. Each sensor's output signal will be processed and filtered to enhance the signal-to-noise ratio. The Trachea Sound Sensor and reference respiratory sensor information will be used to develop/validate risk-index algorithms that can recognize a significant change in an individual's "normal or baseline" pattern of respiratory rate, tidal volume, body activity, and body position. The hypoventilation monitoring system will not require previous knowledge of an individual's age, height, weight, model of the respiratory tract, or external calibration.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Mild Hypoventilation due to an Opioid Overdose
Time Frame: 1 to 3 hours
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
Time Frame: 1 to 3 hours
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
Time Frame: 1 to 3 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Difference Between Trachea Sound Sensor's Measurements and Reference Sensor Measurements
Time Frame: 1 to 3 hours
Correlation between the trachea sound sensor's measurements and the reference sensor measurements of respiratory rate, tidal volume, activity level, and body position during an intravenous infusion of fentanyl (Bland-Altman plot of absolute difference).
1 to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTM Vital Signs, LLC

Collaborators

Thomas Jefferson University

Investigators

  • Principal Investigator: Stephen McNulty, DO, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2019

Primary Completion (Anticipated)

May 14, 2020

Study Completion (Anticipated)

May 14, 2020

Study Registration Dates

First Submitted

February 16, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20183438,18C.7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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