Back to search results

Observational Study: Linshom Continuous Predictive Respiratory Sensor for Post-Surgery Breathing Problems

This study is looking at a new device called the Linshom Continuous Predictive Respiratory Monitor (CPRM) to see if it can predict breathing problems (Respiratory Depression Episode or RDE) in patients after non-heart surgery. The Linshom CPRM is a small sensor that measures your breathing patterns. Researchers want to see if it can predict RDE earlier than the standard pulse oximetry (a device that measures oxygen in your blood). You can join if you are 18 or older, having non-heart surgery, receiving oxygen through a face mask in the recovery room, and are already being monitored with pulse oximetry. The study will compare how well the Linshom CPRM predicts RDE compared to current methods, with results expected in 6-12 months. The current status of this study is unclear.

Study design
This is an observational study involving 320 participants. It compares the Linshom CPRM to standard care without assigning participants to different treatments.
What's involved
If you join, you will have an oxygen mask with the Linshom sensor attached in the recovery room for data collection. You will also receive standard postoperative care.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint will be measured at 6-12 months, indicating the duration of follow-up for the study's main goal.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06744790

Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor

Completed
Not specifiedAges 18+Observational
Linshom Medical, Inc.
~320 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Linshom Continuous Predictive Respiratory Monitoring

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Non-inferiority of Linshom CPRM + SOC compared to SOC alone (nurse monitoring + pulse oximetry) with respect to time (in minutes) prior to RDE that it was predicted that an RDE would occur.
Measured over 12 Months

Conditions

Post Surgical Respiratory Failure
Respiratory Complication

Explore related trials

Post Surgical Respiratory FailureRespiratory complicationRespiratory Depression

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Samuel M Galvagno, DO, PhD, MS, MBA, FCCM · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore
  • LaToya Stubbs, MS, CCRC · STUDY_DIRECTOR · University of Maryland, Baltimore

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

≥18 years old undergoing non-cardiac surgery
Post-operative patients admitted to the PACU and expected to stay in the hospital for at least overnight
Receiving supplemental oxygen via face mask in the PACU
On continuous SpO2 saturation monitoring
Receiving standard postoperative of care

Exclusion

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

What this trial measures

  • Non-inferiority of Linshom CPRM + SOC compared to SOC alone (nurse monitoring + pulse oximetry) with respect to time (in minutes) prior to RDE that it was predicted that an RDE would occur.12 Months

    The primary analysis will be to assess non-inferiority of Linshom + SOC to SOC alone (nurse monitoring + pulse oximetry) with respect to the time (in minutes) prior to RDE that it was predicted that an RDE would occur.This analysis will be performed on patients with RDE. The statistical test to be used will be a paired t-test for non-inferiority of means.