Acute respiratory compromise on inpatient wards in the United States: Incidence, outcomes, and factors associated with in-hospital mortality.
Lars W Andersen, Katherine M Berg, Maureen Chase...
https://pubmed.ncbi.nlm.nih.gov/27255952Actively Recruiting
Led by Linshom Medical, Inc. · Updated on 2024-12-20
320
Participants Needed
1
Research Sites
N/A
Total Duration
L
Linshom Medical, Inc.
Lead Sponsor
M
Maryland Industrial Partnerships
Collaborating Sponsor
Researchers are evaluating a new device called the Linshom Continuous Predictive Respiratory Monitor (CPRM) to improve the early detection of respiratory depression episodes (RDE) in patients recovering from non-cardiac surgery. This observational study involves 320 post-operative patients in the Post Anesthesia Care Unit (PACU) who receive supplemental oxygen and continuous monitoring. The study aims to compare the Linshom CPRM's ability to predict respiratory decline earlier than the current standard of care, including pulse oximetry and capnography. During the study, each participant will be fitted with a face mask containing the Linshom sensor connected to a monitor for continuous data collection. Additional monitoring devices include standard pulse oximeters and capnography equipment. Data will be recorded every second throughout the patient's entire stay in the PACU. Clinical interventions such as medication or oxygen adjustments will be noted alongside the sensor data, but the clinical staff will not have access to the Linshom CPRM data during the study. Participants will undergo continuous respiratory monitoring while receiving standard postoperative care. Research staff will collect detailed information on respiratory parameters like respiratory rate, tidal volume, and minute ventilation using the Linshom device. The main outcome measured is the Linshom CPRM's ability to predict respiratory depression episodes earlier than pulse oximetry. Data collection will continue through the PACU stay, and the study will analyze both non-inferiority and superiority of Linshom CPRM compared to current monitoring methods over 6 to 24 months.
CONDITIONS
Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Overnight post-operative hospital stay
Participants are observed using the Linshom Continuous Predictive Respiratory Monitor alongside standard pulse oximetry and capnography to track respiratory parameters after non-cardiac surgery.
Continuous monitoring during hospital stay in the Post-Anesthesia Care Unit (PACU)
Total: 1 location
1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
J
James R Hughen, MBA
R
Ronen Feldman, BS
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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