Status:
NOT_YET_RECRUITING
Respiratory Monitoring System That Detects & Predicts OIRD
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
RTM Vital Signs, LLC
National Institute of Drug Abuse
Conditions:
Respiration Disorders
Eligibility:
All Genders
18+ years
Brief Summary
This study is being conducted to evaluate the ability of the Respiratory Monitoring System (RMS) to detect and predict opioid induced respiratory depression (OIRD) in post-operative surgical patients ...
Detailed Description
TJU research personnel will be trained by RTM personnel to ensure all questions related to the proper use of the device and study methods are addressed prior to application and use. Subject Screening...
Eligibility Criteria
Inclusion
- Surgical patients routinely managed post-op with opioid medication as their primary analgesic for break through pain.
- Age ≥ 18 years
- BMI 20 to 40
- American Society of Anesthesiologists physical status I, II, and III.
- Understands written and spoken English language
Exclusion
- Age \< 18 years.
- BMI \< 20 or \> 40.
- American Society of Anesthesiologists physical status IV and V.
- Active Do Not Resuscitate (DNR) order.
- Does not understand written and spoken English well.
- Anxiety or claustrophobia related to wearing a face mask or nasal cannula.
- History of skin irritation or inflammation related to the adhesives or materials used in the TSS sensor, facemask, nasal cannula, or pulse oximeter probe.
- Active infection or inflammation of the skin above the proximal trachea.
- Anticipated hospital length of stay less than 24 hours.
- Excessive facial hair that may prevent a tight seal around the facemask.
- Unstable cardiovascular or pulmonary function or any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff (e.g., known history of hepatitis B or C).
- Pregnancy or breast feeding.
- Current participation in an industry sponsored pharmaceutical study or a medical device study.
Key Trial Info
Start Date :
November 3 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07217197
Start Date
November 3 2025
End Date
November 30 2026
Last Update
October 15 2025
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107