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)
2 other identifiers
interventional
394
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2026
CompletedFirst Posted
Study publicly available on registry
August 31, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 6, 2028
September 1, 2026
August 1, 2026
11 months
August 24, 2026
August 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure the number of Respiratory Depression Events (RDE) of Linshom CPRM + standard of care (SOC) vs. SOC alone.
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 Outcomes (1)
Measure the length (in seconds) of RDE per patient with Linshom CPRM + standard of care (SOC) vs. SOC alone.
12 months
Other Outcomes (1)
Measure the Mean/Median Cumulative RDE Time Per Patient in Linshom + SOC vs. SOC alone.
12 months.
Study Arms (1)
Post surgical (non-cardiac) PACU patients with anticipated overnight stay.
EXPERIMENTALThe 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: 1. At least 18 years of age undergoing non-cardiac surgery 2. Post-operative patients admitted to the post-anesthesia care unit (PACU) and expected to stay in the hospital for at least overnight. 3. Receiving supplemental oxygen via face mask or nasal cannula in the PACU 4. On continuous SpO2 saturation monitoring 5. Receiving standard postoperative care Exclusion Criteria: 1. Requirement for any form of postoperative invasive ventilatory support 2. Patients receiving only local or topical anesthesia 3. Day/outpatient surgery 4. Unable to cooperate with the application of the study device 5. Surgical/nursing/anesthesia staff suggest no study-related monitoring because of medical situation
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Linshom Medical, Inc.lead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Ohio State Universitycollaborator
Study Sites (2)
Linshom Medical, Inc.
Baltimore, Maryland, 21230, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard D Urman, MD, MBA
Ohio State University
- STUDY DIRECTOR
Alberto Uribe, MD
Ohio State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2026
First Posted
August 31, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
August 15, 2027
Study Completion (Estimated)
January 6, 2028
Last Updated
September 1, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
Data and specimens will only be shared with individuals who are members of the IRB approved research team or approved for sharing as described in this IRB protocol.