Actively Recruiting

Age: 18Years +
All Genders
ID06744790

Linshom Continuous Predictive Respiratory Monitor (CPRM) for Prediction of Patient Respiratory Decline

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

320

Participants Needed

1

Research Sites

N/A

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

Researchers are evaluating a new device called the Linshom Continuous Predictive Respiratory Monitor (CPRM) to improve the early detection of respiratory depression episodes (RDE) in patients recovering from non-cardiac surgery. This observational study involves 320 post-operative patients in the Post Anesthesia Care Unit (PACU) who receive supplemental oxygen and continuous monitoring. The study aims to compare the Linshom CPRM's ability to predict respiratory decline earlier than the current standard of care, including pulse oximetry and capnography. During the study, each participant will be fitted with a face mask containing the Linshom sensor connected to a monitor for continuous data collection. Additional monitoring devices include standard pulse oximeters and capnography equipment. Data will be recorded every second throughout the patient's entire stay in the PACU. Clinical interventions such as medication or oxygen adjustments will be noted alongside the sensor data, but the clinical staff will not have access to the Linshom CPRM data during the study. Participants will undergo continuous respiratory monitoring while receiving standard postoperative care. Research staff will collect detailed information on respiratory parameters like respiratory rate, tidal volume, and minute ventilation using the Linshom device. The main outcome measured is the Linshom CPRM's ability to predict respiratory depression episodes earlier than pulse oximetry. Data collection will continue through the PACU stay, and the study will analyze both non-inferiority and superiority of Linshom CPRM compared to current monitoring methods over 6 to 24 months.

CONDITIONS

Brief 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 and expected to stay in the hospital overnight
  • Receiving supplemental oxygen via face mask in the PACU
  • On continuous SpO2 saturation monitoring
  • Receiving standard postoperative care
Not Eligible

You will not qualify if you...

  • Requirement for any form of postoperative invasive ventilatory support
  • Patients receiving only local or topical anesthesia
  • Day or outpatient surgery
  • Unable to cooperate with the application of the study device
  • Surgical, nursing, or anesthesia staff suggest no study-related monitoring due to medical condition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Overnight post-operative hospital stay

Participants are observed using the Linshom Continuous Predictive Respiratory Monitor alongside standard pulse oximetry and capnography to track respiratory parameters after non-cardiac surgery.

Continuous monitoring during hospital stay in the Post-Anesthesia Care Unit (PACU)

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

R

Ronen Feldman, BS

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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Frequently Asked Questions

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Published Research Related To This Trial

Acute respiratory compromise on inpatient wards in the United States: Incidence, outcomes, and factors associated with in-hospital mortality.

Lars W Andersen, Katherine M Berg, Maureen Chase...

https://pubmed.ncbi.nlm.nih.gov/27255952

Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial.

Ashish K Khanna, Sergio D Bergese, Carla R Jungquist...

https://pubmed.ncbi.nlm.nih.gov/32925318

Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia.

Frank J Overdyk, Rickey Carter, Ray R Maddox...

https://pubmed.ncbi.nlm.nih.gov/17646499

Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study.

Andreas H Taenzer, Joshua B Pyke, Susan P McGrath...

https://pubmed.ncbi.nlm.nih.gov/20098128

Using the STOP-BANG questionnaire to predict hypoxaemia in patients recovering from noncardiac surgery: a prospective cohort analysis.

A K Khanna, D I Sessler, Z Sun...

https://pubmed.ncbi.nlm.nih.gov/27106966