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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)

28 augusti 2026 uppdaterad av: Linshom Medical, Inc.

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).

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

394

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Maryland
    • Ohio
      • Columbus, Ohio, Förenta staterna, 43210
        • Ohio State University Wexner Medical Center
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Richard D Urman, MD, MBA

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Enhet: Linshom Continuous Predictive Respiratory Monitoring
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.
Andra namn:
  • Pulsoximetri

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Measure the number of Respiratory Depression Events (RDE) of Linshom CPRM + standard of care (SOC) vs. SOC alone.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Measure the length (in seconds) of RDE per patient with Linshom CPRM + standard of care (SOC) vs. SOC alone.
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Measure the Mean/Median Cumulative RDE Time Per Patient in Linshom + SOC vs. SOC alone.
Tidsram: 12 months.
Demonstrate that Linshom Medical + SOC can reduce the Mean/Median Cumulative RDE Time Per Patient vs. SOC alone.
12 months.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Linshom Medical, Inc.

Samarbetspartners

National Heart, Lung, and Blood Institute (NHLBI)
Ohio State University

Utredare

  • Huvudutredare: Richard D Urman, MD, MBA, Ohio State University
  • Studierektor: Alberto Uribe, MD, Ohio State University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

15 augusti 2027

Avslutad studie (Beräknad)

6 januari 2028

Studieregistreringsdatum

Först inskickad

24 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

26 augusti 2026

Första postat (Faktisk)

31 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SB1HL182474 (U.S.S. NIH-anslag/kontrakt)
  • 1SB1HL182474-01 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

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