RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Investigators will enroll 320 patients who will undergo non-cardiac surgery, receive supplemental oxygen via face mask, and will be on a continuous pulse oximetry monitor in the Post Anesthesia Care Unit (PACU). The enrollment criteria were adapted from a previous study that showed SpO2 values seriously underestimated the severity of post-operative hypoxemia in patients with and without specific risk factors for hypoxemia. Research personnel will screen and ensure that each subject meets the enrollment criteria, and the informed consent is properly executed. Upon arrival to the PACU, each subject will be fitted with oxygen mask containing the Linshom sensor, which will be connected to a Linshom monitor for data collection. A side stream capnography line will be connected to the same face mask and the capnography data will be collected on the Zoe Medical 740 SELECT™ monitor. Additionally, two pulse oximeters will be applied to the same hand (non- NIBP arm), one of which will be connected to a hospital monitor (SoC) and the other to a Zoe Medical 740 SELECT™ monitor. The Linshom and 740 SELECT™ monitors will collect data once every second. Research personnel will then initiate the Linshom CPRM baseline mode and begin recording any clinical intervention (e.g., medications, oxygen delivery change, and stimulation upon detection of changes in patient's condition) that is performed by the PACU staff, paying close attention to, and recording of time at which those interventions occurred. Data collection will be performed throughout the subject's entire PACU stay. The CPRM data collection will be performed passively while the patient is monitored via SoC and will not interfere with clinical interventions that may take place during the data collection. Clinical staff in the PACU will be blinded to the Linshom CPRM data as well as pulse oximetry (non-SOC monitor) and capnography data collected.

Official Title

Linshom Continuous Predictive Respiratory Monitor (CPRM) for Prediction of Patient Respiratory Decline

Quick Facts

Study Start:2023-06-21
Study Completion:2025-06-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06744790

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years old undergoing non-cardiac surgery
  2. * Post-operative patients admitted to the PACU and expected to stay in the hospital for at least overnight
  3. * Receiving supplemental oxygen via face mask in the PACU
  4. * On continuous SpO2 saturation monitoring
  5. * Receiving standard postoperative of care
  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

Contacts and Locations

Study Contact

James R Hughen, MBA
CONTACT
443-994-1448
rhughen@linshomforlife.com
Ronen Feldman, BS
CONTACT
410-480-2700
rfeldman@linshomforlife.com

Principal Investigator

Samuel M Galvagno, DO, PhD, MS, MBA, FCCM
PRINCIPAL_INVESTIGATOR
University of Maryland Medical Center
LaToya Stubbs, MS, CCRC
STUDY_DIRECTOR
University of Maryland Medical Center

Study Locations (Sites)

University of Maryland Medical Center
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: Linshom Medical, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-21
Study Completion Date2025-06-16

Study Record Updates

Study Start Date2023-06-21
Study Completion Date2025-06-16

Terms related to this study

Keywords Provided by Researchers

  • Respiratory Decline
  • Respiratory Complication
  • Respiratory Depression
  • Post Surgical Respiratory Failure
  • Continuous Monitoring
  • Continuous Respiratory Monitoring
  • respiratory
  • monitoring
  • pulse oximetry
  • capnography
  • Linshom

Additional Relevant MeSH Terms

  • Post Surgical Respiratory Failure
  • Respiratory Complication