Actively Recruiting
Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor
Led by Linshom Medical, Inc. · Updated on 2024-12-20
320
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
L
Linshom Medical, Inc.
Lead Sponsor
M
Maryland Industrial Partnerships
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older undergoing non-cardiac surgery
- Post-operative patients admitted to the PACU with an expected hospital stay of at least overnight
- Receiving supplemental oxygen via face mask in the PACU
- On continuous pulse oximetry (SpO2) monitoring
- Receiving standard postoperative care
You will not qualify if you...
- Need for any form of postoperative invasive ventilatory support
- Receiving only local or topical anesthesia
- Undergoing day or outpatient surgery
- Unable to cooperate with the application of the study device
- Medical staff recommend no study monitoring due to medical situation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
J
James R Hughen, MBA
CONTACT
R
Ronen Feldman, BS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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