Actively Recruiting

Age: 18Years +
All Genders
NCT06744790

Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor

Led by Linshom Medical, Inc. · Updated on 2024-12-20

320

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

Sponsors

L

Linshom Medical, Inc.

Lead Sponsor

M

Maryland Industrial Partnerships

Collaborating Sponsor

AI-Summary

What this Trial Is About

Investigators will enroll 320 patients who will undergo non-cardiac surgery, receive supplemental oxygen via face mask, and will be on a continuous pulse oximetry monitor in the Post Anesthesia Care Unit (PACU). The enrollment criteria were adapted from a previous study that showed SpO2 values seriously underestimated the severity of post-operative hypoxemia in patients with and without specific risk factors for hypoxemia. Research personnel will screen and ensure that each subject meets the enrollment criteria, and the informed consent is properly executed. Upon arrival to the PACU, each subject will be fitted with oxygen mask containing the Linshom sensor, which will be connected to a Linshom monitor for data collection. A side stream capnography line will be connected to the same face mask and the capnography data will be collected on the Zoe Medical 740 SELECT™ monitor. Additionally, two pulse oximeters will be applied to the same hand (non- NIBP arm), one of which will be connected to a hospital monitor (SoC) and the other to a Zoe Medical 740 SELECT™ monitor. The Linshom and 740 SELECT™ monitors will collect data once every second. Research personnel will then initiate the Linshom CPRM baseline mode and begin recording any clinical intervention (e.g., medications, oxygen delivery change, and stimulation upon detection of changes in patient's condition) that is performed by the PACU staff, paying close attention to, and recording of time at which those interventions occurred. Data collection will be performed throughout the subject's entire PACU stay. The CPRM data collection will be performed passively while the patient is monitored via SoC and will not interfere with clinical interventions that may take place during the data collection. Clinical staff in the PACU will be blinded to the Linshom CPRM data as well as pulse oximetry (non-SOC monitor) and capnography data collected.

CONDITIONS

Official Title

Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older undergoing non-cardiac surgery
  • Post-operative patients admitted to the PACU with an expected hospital stay of at least overnight
  • Receiving supplemental oxygen via face mask in the PACU
  • On continuous pulse oximetry (SpO2) monitoring
  • Receiving standard postoperative care
Not Eligible

You will not qualify if you...

  • Need for any form of postoperative invasive ventilatory support
  • Receiving only local or topical anesthesia
  • Undergoing day or outpatient surgery
  • Unable to cooperate with the application of the study device
  • Medical staff recommend no study monitoring due to medical situation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

Actively Recruiting

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Research Team

J

James R Hughen, MBA

CONTACT

R

Ronen Feldman, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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