About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old undergoing non-cardiac surgery
Post-operative patients admitted to the PACU and expected to stay in the hospital for at least overnight
Receiving supplemental oxygen via face mask in the PACU
On continuous SpO2 saturation monitoring
Disqualifiers
Requirement for any form of postoperative invasive ventilatory support
Patients receiving only local or topical anesthesia
Day/outpatient surgery
Unable to cooperate with the application of the study device
Trial population
This study will be conducted at The University of Maryland Medical Center (UMMC) where about 9% of the surgical procedures will go to the ICU or other non-PACU location and 20% will go home same day (within 24 hours). Based on previous trial data from UMMC, investigators expect gender to be \~50% male, 76% white and 23% non-white with an age distribution of 1/3 \< 60 years of age and 2/3 \> 60 years of age. This enrollment criteria makes the study results generalizable; population balanced and supports enrollment.
Trial design
Case-control
Prospective
Treatments tested in this trial
Linshom Continuous Predictive Respiratory Monitoring
DeviceObservational study. Monitoring of Linshom, pulse oximetry and capnography data with comparison to current standard of care.
Treatment groups
Trial outcomes
Primary outcomes
Non-inferiority of Linshom CPRM to pulse oximetry with respect to the time (in minutes) prior to RDE that it was predicted that an RDE would occur.
The primary analysis will be to assess non-inferiority of Linshom to pulse oximetry with respect to the time (in minutes) prior to RDE that it was predicted that an RDE would occur.This analysis will be performed on patients with RDE. The statistical test to be used will be a paired t-test for non-inferiority of means.
Secondary outcomes
Superiority of Linshom CPRM to pulse oximetry, capnography and pulse oximetry + capnography with respect to the time (in minutes) prior to RDE that it was predicted that an RDE would occur.
Under the same assumptions of mean difference and standard deviation of the paired difference as for Phase I above, but with a -1 minute noninferiority margin, then a sample size of 128 subjects with RDE has 80% power to claim noninferiority of Linshom to pulse oximetry (i.e., 80% power to reject the above null hypothesis) at a one-sided 0.025 level of significance. Assuming prevalence of RDE in the PACU population is 40%, then 320 subjects will be enrolled in Phase I and II combined to achieve128 subjects with RDE for the Phase I + II combined primary analysis.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Linshom Medical, Inc.
Lead sponsor
Maryland Industrial Partnerships
Collaborator
University of Maryland, Baltimore
Collaborator