Post Surgical Respiratory FailureNCT07793981
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)
A study testing Linshom Continuous Predictive Respiratory Monitoring in people with Post Surgical Respiratory Failure and Respiratory Complication, run by Linshom Medical, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Surgical Respiratory Failure, Respiratory Complication, Opioid Induced Respiratory Depression
- What is being tested?
- Linshom Continuous Predictive Respiratory Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2026to 6 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Linshom Medical, Inc.
Baltimore, Maryland, 21230
James R Hughen, MBA, 443-994-1448, rhughen@linshommedical.com
Ronen Feldman, BS, 443-472-6188, rfeldman@linshommedical.com
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Richard D Urman, MD, MBA, 614-293-5188, richard.urman@osumc.edu
Alberto Uribe, MD, 614-293-3559, alberto.uribe@osumc.edu
About this study
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).
Read the 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.
- Conditions
- Post Surgical Respiratory Failure, Respiratory Complication, Opioid Induced Respiratory Depression, Respiratory Arrest
- Being tested
- Linshom Continuous Predictive Respiratory Monitoring
- Keywords
- respiratory, monitoring, pulse oximetry, Linshom, capnography, respiratory depression
- Medical subject headings
- Apnea, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linshom Continuous Predictive Respiratory MonitoringDevice
Also called Pulse Oximetry
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.
| Study group | Role | What they receive |
|---|---|---|
| Post surgical (non-cardiac) PACU patients with anticipated overnight stay. | Experimental | 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:
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 Receives: Device: Linshom Continuous Predictive Respiratory Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Measure the length (in seconds) of RDE per patient with Linshom CPRM + standard of care (SOC) vs. SOC alone.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion6 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Surgical Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospectively studied patients will be monitored for detection and intervention of respiratory depression events (RDEs). Data will be compared to historical control from previous study (https://clinicaltrials.gov/study/NCT05804175).
- Masking
- None (open label)
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linshom Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard D Urman, MD, MBA, Principal investigator, Ohio State UniversityAlberto Uribe, MD, Study director, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793981
- Sponsor's protocol ID
- SB1HL182474
- Other IDs
- 1SB1HL182474-01
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.