Condition: Post Surgical Respiratory Failure · Respiratory Complication · Sponsor: Linshom Medical, Inc.
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 occ…
This description comes directly from the study's public registry record.
James R Hughen, MBA · 443-994-1448 · rhughen@linshomforlife.com
Ronen Feldman, BS · 410-480-2700 · rfeldman@linshomforlife.com
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| University of Maryland Medical Center | Baltimore, Maryland, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06744790