Clinical Evaluation of an Alarm Activated Detection System to Enable Early Intervention of Emerging Respiratory Decline With the Linshom Medical Continuous Predictive Respiratory Sensor (CPRS)
Investigators will enroll 493 patients who will undergo non-cardiac surgery, receive supplemental oxygen via face mask or nasal cannula, and will be on continuous pulse oximetry monitor in the Post Anesthesia Care Unit (PACU). Research personnel will screen and select subjects for this study. The CRA will ensure that each subject meets the enrollment criteria, and the informed consent is properly executed. Upon arrival at the PACU, each subject will be fitted with a supplemental oxygen mask or nasal cannula containing the Linshom sensor, which will be connected to Linshom Cyber G-15 monitor for data collection. A pulse oximeter will be applied to the hand (non-NIBP arm), which will be connected to a hospital monitor (SOC). The Linshom G-15 monitor will collect data every 100 milliseconds. The Linshom CPRM will automatically initiate baseline data capture. The CRA will begin recording any clinical interventions (e.g., medications and stimulation upon detection of changes in patient's condition) that are performed by the PACU staff, paying close attention to time at which those interventions occurred. Data collection will be performed throughout the subject's entire PACU stay. After data collection, the Linshom engineers will retrieve the data from all monitors and time-sync all data collected from each patient (Linshom CPRM and pulse oximetry). Manually recorded data regarding the time points at which clinical interventions were provided by the PACU staff will also be reviewed and those time points will be noted as RDEs.
The Linshom CPRM system monitors the distinct metric of RDE occurrence. Throughout a given patient's stay, nurses will be provided with two distinct cues (each cue comprised of an auditory and visual component), 1 from CPRM, 1 from SoC, alerting them to a patient's respiratory state. In addition, clinical staff will have access to a summary metrics of critical parameters and RDE occurrences on the Linshom monitor (total RDE count, time since last RDE).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Linshom has developed the Continuous Predictive Respiratory Monitoring (CPRM) system, designed to alert clinicians of active or impending respiratory distress events. The system features a miniaturized version of the FDA cleared Linshom Continuous Predictive Respiratory Sensor - a small, wearable sensor that provides continuous real-time tracking of the critical indicators of RDE. Linshom offers an OR-quality respiratory profile at the patient bedside, which allows health care providers to promptly diagnose emerging respiratory decline and intervene with appropriate medical care. The technology is based on a novel thermal sensor which is regulated by a thermo-electric cooler utilizing a proprietary control loop process. Respiration state is measured via temperature change throughout a patients inspiratory/expiratory cycle. This delivers a respiratory signature allowing for continuous measurement of RR, rTV, rMV, SSLB, apnea detection, and I/E ratio. The CPRM system solves the unmet need for a small, portable, sensor and monitor that tracks RR, rTV, rMV, seconds since last breath (SSLB), and I:E ratio in real time and continuously. These parameters are crucial in monitoring of patients suffering from both acute and chronic respiratory illness.
The main focus will be performing an unblinded trial where the CPRM system is actively used to guide clinical intervention with the aim of reducing burden of RDEs, which will provide critical evidence of the clinical care and health economic cost benefits of the CPRM system.
Specific aim:
Conduct an unblinded clinical trial to demonstrate that Linshom CPRM + standard of care (SOC) can reduce Respiratory Depression Episodes by at least 30% compared to SOC alone.
Outcome: Demonstrate that the CPRM system can reduce the frequency and length of RDE events more effectively than SOC alone (continuous pulse oximetry and 1 on 1 nursing care) when utilized as an alert system by nursing staff.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: James R Hughen, MBA
- Phone Number: 443-994-1448
- Email: rhughen@linshommedical.com
Study Contact Backup
- Name: Ronen Feldman, BS
- Phone Number: 443-472-6188
- Email: rfeldman@linshommedical.com
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21230
- Linshom Medical, Inc.
-
Contact:
- James R Hughen, MBA
- Phone Number: 443-994-1448
- Email: rhughen@linshommedical.com
-
Contact:
- Ronen Feldman, BS
- Phone Number: 443-472-6188
- Email: rfeldman@linshommedical.com
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Wexner Medical Center
-
Contact:
- Richard D Urman, MD, MBA
- Phone Number: 614-293-5188
- Email: richard.urman@osumc.edu
-
Contact:
- Alberto Uribe, MD
- Phone Number: 614-293-3559
- Email: alberto.uribe@osumc.edu
-
Principal Investigator:
- Richard D Urman, MD, MBA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years of age undergoing non-cardiac surgery
- Post-operative patients admitted to the post-anesthesia care unit (PACU) and expected to stay in the hospital for at least overnight.
- Receiving supplemental oxygen via face mask or nasal cannula in the PACU
- On continuous SpO2 saturation monitoring
- Receiving standard postoperative care
Exclusion Criteria:
- Requirement for any form of postoperative invasive ventilatory support
- Patients receiving only local or topical anesthesia
- Day/outpatient surgery
- Unable to cooperate with the application of the study device
- Surgical/nursing/anesthesia staff suggest no study-related monitoring because of medical situation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Post surgical (non-cardiac) PACU patients with anticipated overnight stay.
The intervention will be the institutional standard of care (SOC) intervention(s) for any patient experiencing a RDE (typically an apnea ≥ 30 seconds). Typical interventions may include patient arousal, patient re-positioning, supplemental oxygen administration and other SOC. Inclusion Criteria:
Exclusion Criteria:
|
Linshom CPRM with alarms enabled will be used to alert nurses of respiratory issues.
Action will be taken based on nurse assessment and will follow standard of care procedures.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure the number of Respiratory Depression Events (RDE) of Linshom CPRM + standard of care (SOC) vs. SOC alone.
Time Frame: 12 months
|
Demonstrate that the CPRM system can reduce the frequency of RDE events more effectively than SOC alone (continuous pulse oximetry and 1 on 1 nursing care) when utilized as an alert system by nursing staff. The statistical test to be used is a negative binomial regression model, which is appropriate for modeling count data (RDE rates) with potential overdispersion. |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure the length (in seconds) of RDE per patient with Linshom CPRM + standard of care (SOC) vs. SOC alone.
Time Frame: 12 months
|
Demonstrate that the CPRM system can reduce the length of RDE events more effectively than SOC alone (continuous pulse oximetry and 1 on 1 nursing care) when utilized as an alert system by nursing staff. The statistical tests will evaluate: Mean/Median Time Per RDE. |
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure the Mean/Median Cumulative RDE Time Per Patient in Linshom + SOC vs. SOC alone.
Time Frame: 12 months.
|
Demonstrate that Linshom Medical + SOC can reduce the Mean/Median Cumulative RDE Time Per Patient vs. SOC alone.
|
12 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard D Urman, MD, MBA, Ohio State University
- Study Director: Alberto Uribe, MD, Ohio State University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Signs and Symptoms, Respiratory
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Respiratory Insufficiency
- Apnea
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Respiratory System
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Respiratory Function Tests
- Blood Chemical Analysis
- Clinical Chemistry Tests
- Blood Gas Analysis
- Oximetry
Other Study ID Numbers
- SB1HL182474 (U.S. NIH Grant/Contract)
- 1SB1HL182474-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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