Linshom Respiratory Monitoring for Respiratory Complications

Not yet recruiting at 1 trial location
JR
RF
Overseen ByRonen Feldman, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Linshom Medical, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

AU

Alberto Uribe, MD

Principal Investigator

Ohio State University

RD

Richard D Urman, MD, MBA

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for adults having non-heart surgery who will need extra oxygen and monitoring in the recovery room. Participants must be able to give consent and meet screening requirements set by the research team.

Inclusion Criteria

On continuous SpO2 saturation monitoring
I am using oxygen through a mask or nasal tube after surgery.
I am staying in the hospital overnight after surgery.
See 2 more

Exclusion Criteria

Surgical/nursing/anesthesia staff suggest no study-related monitoring because of medical situation
I am unable to use or cooperate with the study device.
I am only receiving local or topical anesthesia.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Linshom Continuous Predictive Respiratory Monitoring

Trial Overview

The study tests a new continuous respiratory sensor (Linshom CPRM) that monitors breathing after surgery, comparing its alerts to standard pulse oximetry. Nurses use both systems' alarms to detect early breathing problems.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Post surgical (non-cardiac) PACU patients with anticipated overnight stay.Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Linshom Medical, Inc.

Lead Sponsor

Trials
2
Recruited
920+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Ohio State University

Collaborator

Trials
891
Recruited
2,659,000+