The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms during esophagogastroduodenoscopy (EGD) or colonoscopy.
Study Type
OBSERVATIONAL
Enrollment
51
propofol sedation with the SEDASYS System
ProMedica Toledo Hospital
Toledo, Ohio, United States
Percent of documented responses/actions taken in response to SEDASYS System alarms (oxygen desaturation, apnea, hypotension, and bradycardia alarms)
Time frame: <24 hours, i.e., for duration of study procedure
Fraction of users responses/actions to oxygen desaturation, apnea, hypotension, and/or bradycardia alarms deemed sufficient by Endpoint Adjudication Committee (EAC)
Time frame: assessment of sufficient alarms will be reviewed by EAC after 100, 400, and 866 subjects completed the study
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