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)

Conditions

• Opioid Induced Respiratory Depression
• Post Surgical Respiratory Failure
• Respiratory Arrest
• Respiratory Complication

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Linshom Continuous Predictive Respiratory Monitoring — DEVICE
  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 Details

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).

Key Dates

First listed

Aug 31, 2026

Start date

Oct 1, 2026

Status verified

Aug 2026

Primary completion

Aug 15, 2027

Completion

Jan 6, 2028

Study Design

Enrollment

394 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• 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: 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

Primary Outcome Measure

Measure the number of Respiratory Depression Events (RDE) of Linshom CPRM + standard of care (SOC) vs. SOC alone. [ Time Frame: 12 months ]

Central Contacts

• James R Hughen, MBA
  443-994-1448
  [email protected]
• Ronen Feldman, BS
  443-472-6188
  [email protected]

Locations (2)

Find similar trials in Baltimore, MD

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